Medtronic SC5100FV Instructions for Use
Complete® SE
Vascular Stent System
Instructions for Use
Trademarks may be registered and are the property of their respective owners.
1
EXPLANATION OF SYMBOLS ON PRODUCT LABELING
Refer to the device labeling to see which symbols apply to this product.
Contents: One device
Do not use if package is damaged
Non-pyrogenic
Peel here
MR Conditional
CAUTION: Federal (USA) law restricts this device for sale by or on order of a physician.
Sterilized using irradiation
Catalogue number
Use by
Do not reuse
Manufacturer
Manufactured In
Consult instructions for use at: www.medtronic.com/manuals
Lot number
Do not use if indicator turns black
Minimum sheath ID
Store at room temperature in a dark, dry place
Stent inner diameter
Stent length
2
Complete® SE
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2
3
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Vascular Stent System - Superficial Femoral Artery (SFA)/Proximal Popliteal Artery (PPA)
1. Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4. Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5. Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6. Summary of Clinical Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7. Patient Selection and Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8. Patient Counseling Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
9. How Supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10. Clinical Use Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
11. Implant Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
12. Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1. Device Description
The Complete SE vascular stent system is used to deliver a self-expanding stent to the superficial femoral/proximal popliteal arteries via a sheathed delivery
system. The system is comprised of 2 main components: the implantable vascular stent (Figure 1) and the disposable delivery system (Figure 2). The stent is
compressed and preloaded into the delivery system (Figure 3) and advanced to the target lesion, where the protective sheath is retracted. Upon deployment,
the stent self-expands to provide a vessel support frame and to impart an outward radial force on the arterial lumen to establish patency.
1.1. Stent
Figure 1. Complete SE Vascular Stent with Tantalum Markers
Note: This and all other product graphics appearing in this manual are not drawn to scale.
The Complete SE vascular stent is constructed of a nickel-titanium alloy (nitinol) and has 4 tantalum radiopaque markers on each end to aid in visualization and
facilitate placement. The series of segments, each connected to the next, allow for flexibility and vessel conformability. It is available in diameters of 5 mm
to 8 mm and lengths of 20 mm to 150 mm. See Table 2 in Recommended Device Sizing (Section 10.2).
1.2. Delivery System
TABLE OF CONTENTS
Figure 2. The Complete SE Vascular Stent Delivery System
1. Tip and flexible outer member sheath 5. Deployment rotation/slider mechanism
2. Outer stability member 6. Deployment button
3. Strain relief 7. Safety lock
4. Front grip
The Complete SE vascular stent delivery system consists of a single-use, disposable catheter with an integrated handle to provide controlled deployment. It
has a working length of either 80 cm or 130 cm and is compatible with a 6 Fr sheath and 0.035 in (0.89 mm) guidewire.
The over-the-wire retractable sheath delivery system is composed of a tip and flexible outer member sheath (braided) body attached to the strain relief handle,
which includes the front grip and the deployment rotation/slider mechanism with a removable safety lock. The outer member sheath is retracted by engaging
the deployment slider/rotation mechanism. Radiopaque marker bands are located on both the distal and proximal sides of the preloaded stent to aid placement
(Figure 3).
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1. Tip
2. Stent sheath
3. Catheter radiopaque marker bands
4. Stent
5. Tantalum markers
2
5
4
3
Figure 3. Complete SE Vascular Stent System
Instructions for Use English 3
The Complete SE vascular stent system does not contain natural rubber latex. However, during the manufacturing/assembly process, it may have incidental
contact with latex-containing products.
2. Indications for Use
The Complete SE vascular stent system is indicated to improve luminal diameter in symptomatic patients with de novo and/or restenotic lesions or occlusions
of the superficial femoral artery (SFA) or proximal popliteal artery (PPA) with reference diameters ranging from 4 mm to 7 mm and lesion lengths up to 140 mm.
3. Contraindications
The Complete SE vascular stent system is contraindicated in:
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patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
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patients who cannot receive antiplatelet or anticoagulation therapy
Also consider patient selection information in Warnings and Precautions (Section 4).
4. Warnings and Precautions Caution: Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions may result in serious consequences or injury to
the patient.
4.1. General
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The Complete SE vascular stent system should only be used by physicians and medical personnel trained in vascular interventional techniques (including
advanced iliac or SFA angioplasty or stenting techniques) and trained on the use of this device. Specific training expectations are described in Physician
Training Requirements (Section 10.1).
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Caution: Federal (USA) law restricts this device for sale by or on the order of a physician.
4.2. Warnings
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Do not use if the temperature indicator found on the inner pouch is changed from a gray square to a black square as this indicates the unconstrained stent
diameter and stent release may be compromised.
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Administer appropriate antiplatelet/anticoagulation therapy pre- and post- procedure. Use of this device in patients who are unable to tolerate appropriate
antiplatelet therapy is not recommended.
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Do not use the Complete SE vascular stent system in patients unable to undergo, or who will not be compliant with, the necessary preoperative and
postoperative imaging and implantation procedures.
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Careful stent sizing is important. In vitro modeling has predicted the Complete SE vascular stent foreshortens between 0% (5 mm stents) and 8% (8 mm
stents). See Table 2 for available diameters and lengths (Section 10.2).
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The use of overlapping stents with the Complete SE vascular stent system has not been formally evaluated in a clinical study; overlap stents have been
evaluated on the bench/Finite Element Analysis (FEA) and results are on file at Medtronic.
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To achieve optimal sizing and apposition to the vessel wall, using an interference fit, stents should be at least 0.5 mm greater in diameter than the target
vessel. Consideration should also be given to the length of the lesion to be treated when selecting the stent length. See Recommended Device Sizing
(Section 10.2).
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To avoid kinking of the delivery system, stabilize the hub of the guiding catheter or introducer sheath, hold the catheter shaft just proximal, and use short
strokes to advance the delivery catheter over the immobilized guidewire.
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Do not deploy the stent if it is not optimal or appropriate for the vessel. The stent cannot be repositioned once the stent has begun to appose the vessel wall.
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Use caution when placing a stent near a bifurcation, aneurysm, or bypass graft.
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Prior to stent deployment, use fluoroscopy to verify the stent has not been damaged or dislodged during positioning.
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If unable to initiate stent release, remove the entire system from the patient and advance a new stent delivery system.
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Once deployment is initiated, the stent cannot be recovered by the sheath. In the event of partial delivery of the stent, remove the entire delivery system
from the patient. This may result in damage to the vessel wall and require surgical intervention.
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Prior to completion of the procedure, use fluoroscopy to ensure the stent is deployed in the proper position. If the target lesion is not completely covered
by the stent, use additional Complete SE vascular stent(s) as necessary to adequately treat the lesion.
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Should unusual resistance be felt at any time during placement or removal of the stent or delivery system, cautiously remove the entire system. Applying
excessive force to the Complete SE vascular self-expanding stent system can potentially result in loss, damage, or partial deployment of the stent and the
delivery system components.
4.3. Precautions
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The Complete SE vascular stent system should only be used by physicians and medical personnel trained in vascular interventional techniques (including
SFA angioplasty or stenting techniques) and trained on the use of this device. Specific training expectations are described in Physician Training
Requirements (Section 10.1).
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The long-term safety and effectiveness of the Complete SE vascular stent system has not been established beyond one year.
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The safety and effectiveness of this system has not been evaluated in patients who:
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are less than 18 years old
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are pregnant or lactating
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have any condition that precludes safe access with PTA devices
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have in-stent restenosis of the target lesion
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have a known hypersensitivity to any component of the stent system (eg, nickel)
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cannot tolerate aspirin and heparin
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cannot tolerate contrast media and cannot be pretreated
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have a history of bleeding diathesis or coagulopathy or will refuse blood transfusion
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have creatinine >2.5 mg/dl
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Inappropriate patient selection may result in poor device performance or device performance otherwise not in accordance with the specifications.
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Thrombogenicity evaluations were conducted using a heparinized model. If your patient cannot be adequately anticoagulated, it is unknown whether
thrombus formation may occur with this product.
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Caution must be taken when crossing the stented area with ancillary equipment to avoid dislodging the stent.
5. Adverse Events
5.1. Observed Adverse Events
Major adverse events observed in the clinical study supporting approval of the device are provided in Section 6.
5.2. Potential Adverse Events
Adverse events that may occur or require intervention include, but are not limited to the following:
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abrupt stent closure
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allergic reaction (contrast medium; drug; stent or filter material)
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amputation or limb loss
4 Instructions for Use English
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aneurysm or pseudoaneurysm in vessel or at vascular access site
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angina or coronary ischemia
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arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation)
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asystole or bradycardia, requiring placement of a temporary pacemaker
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arteriovenous fistula
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bleeding complications from anticoagulant or antiplatelet medication requiring transfusion or surgical intervention
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death
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detachment of a system component or implantation in an unintended site
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emboli, distal (for example, air, tissue, plaque, thrombotic material, or stent)
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emergent bypass surgery to perfuse limb
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fever
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hematoma at vascular access site, with or without surgical repair
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hypotension or hypertension
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infection, local or systemic, including bacteremia or septicemia
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ischemia requiring intervention (bypass or amputation of toe, foot, or leg)
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myocardial infarction
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occlusion of SFA/PPA artery or distal vasculature
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pain (leg or foot)
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pain at catheter insertion site
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pulmonary embolism
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renal failure or insufficiency, secondary to contrast medium
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restenosis of vessel in stented segment
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stent malposition or migration, which may require emergency surgery to remove stent
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stent strut fracture
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stent thrombosis or occlusion
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stroke
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vascular thrombosis or occlusion at puncture site, treatment site, or remote site
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vessel dissection, perforation or rupture
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vessel spasm or recoil
5.3. Device-related Adverse Events
Any adverse event or clinical incident involving the Complete SE vascular stent system should be immediately reported to Medtronic. To report an incident in
the US, call (800) 465-5533.
6. Summary of Clinical Study
The clinical evidence supporting the safety and effectiveness of the Complete SE vascular stent system for the treatment of de novo or restenotic lesions or
occlusions (≤140 mm) in the SFA or PPA in subjects with symptomatic peripheral artery disease (PAD) is from the Complete SE SFA/PPA Study.
6.1. The Complete SE SFA IDE Study
The Complete SE SFA Study is a nonrandomized, prospective, multicenter, single-arm study enrolling up to 196 subjects with symptomatic ischemic PAD
(Rutherford class 2 through 4) with a lesion ≥50%, a target vessel reference diameter ≥4 mm and ≤7 mm, total lesion length ≥40 mm and ≤140 mm (visual
estimates), and adequate distal runoff to the foot. Lesions were located above the knee and amenable to percutaneous treatment with angioplasty and vascular
stent implantation. For treatment of multiple lesions, the combined lesion length must be ≤140 mm. The lesions must be in the same limb, and the treatment
must not require more than 150 mm in combined stent length.
6.1.1. Patient Population
196 subjects were enrolled at 28 sites (United States, Belgium, and Germany) with a mean age of 69 years (range: 40 to 93), including 124 males (63%).
Subject demographics, medical history, and risk factors are summarized (Figure 4).
Instructions for Use English 5
Subject Demographic, Medical History and Risk Factors
a
N = 196
Age (year)
n 196
Mean ± SD 68.7 ± 10.5
Median 68.0
Min, Max 40, 93
Sex % (m/n)
Male 63.3 (124/196)
Medical History and Risk Factors % (m/n)
Diabetes Mellitus 45.4 (89/196)
Type I 1.5 (3/196)
Type II 43.9 (86/196)
Dyslipidemia 79.6 (156/196)
Hypertension 90.3 (177/196)
History of Tobacco Use 79.6 (156/196)
Former 52.6 (103/196)
Current 27.0 (53/196)
History of Coronary Artery Disease 62.8 (123/196)
History of COPD 21.4 (42/196)
Previous MI 26.2 (49/187)
Previous Peripheral Vascular Disease (other than SFA and PPA)
53.1 (103/194)
History of CVA
14.3 (28/196)
Previous PTA/Stenting to Target Limb 18.4 (36/196)
Previous Aorta/Peripheral Bypass to Target Limb 1.5 (3/196)
History of GI/GU Bleed 5.6 (11/196)
a Based on number of subjects with available data
N = Intent-To-Treat Population
Note: Site Reported Table
6.1.2. Methods
Direct stent placement was at the discretion of the physician. The target lesion was to be predilated (with standard PTA balloons) if necessary to cross the lesion.
Prior to the procedure, the subject was given an oral dose of aspirin (325 mg). Prior to stent placement, heparin was administered to achieve ACT. Target lesions
were treated with 1 or 2 stents.
6 Instructions for Use English
Figure 4. Subject Demographics, Medical History, and Risk Factors
Angiographic Quantitative
Analysis
a
Lesionsb= 213
Reference vessel diameter (mm)
Mean±SD (n) 4.8±0.9 (209)
Minimum, maximum 2.2, 7.6
Lesion length (total) (mm)
Mean±SD (n) 60.7±37.6 (209)
Minimum, maximum 5, 228
Lesion pre-procedure % stenosis
Mean±SD (n) 79.7±16.1 (209)
Minimum, maximum 51.1, 100
Lesion post-procedure % stenosis
Mean±SD (n) 16.9±9.3 (211)
Minimum, maximum 1.4, 40.5
Lesions treated with 1 study stent
203
Lesions treated with 2 study stents
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Lesion Characteristic
% (m/n)
Eccentric 31 (65/210)
Ulceration 17.6 (37/210)
Calcification 91 (191/210)
None/Mild 9 (19/210)
Moderate 34.8 (73/210)
Severe 56.2 (118/210)
Thrombus
0 (0/210)
Total Occlusion
29.9 (60/201)
Dissection Grade
0 (no dissection) 97.2 (205/211)
A0 (0/211)
B 1.9 (4/211)
C 0.5 (1/211)
D 0.5 (1/211)
E0 (0/211)
F0 (0/211)
a
Based on the number of lesions with available data.
b
Lesions as Angiographic Core Laboratory Reported.
Lesion Location (%)
SFA Ostial 2.3 (5/213)
SFA Proximal 13.6 (29/213)
SFA Mid
SFA Distal
Proximal Popliteal Artery
34.4 (73/213)
45.5 (97/213)
4.2 (9/213)
6.1.3. Study Results: Safety Endpoint
The primary safety endpoint is the major adverse event (MAE) rate at 12 months. MAE is defined as device or procedure related death (or any death occurring
postprocedure through 30 days), target limb loss, and target lesion or target vessel revascularization. Primary safety endpoints are summarized in Figure 6.
Figure 5. Lesion Characteristics
Instructions for Use English 7
Figure 6. Primary Safety Endpoint
N = 196
Lesions
b
= 213
Primary Safety Endpoint % (m/n)
a
Exact One-
sided
Upper
97.5% CI
MAE at 12 Months 11.0 (21/191) 16.3%
Death through 30 Days 0.0 (0/191) 1.9%
Death (Device and/or Procedure Related) 0.0 (0/191) 1.9%
Device Related 0.0 (0/191) 1.9%
Procedure Related 0.0 (0/191) 1.9%
Target Limb Loss 0.5 (1/191) 2.9%
TLR 9.4 (18/191) 14.5%
PTA 8.9 (17/191) 13.9%
Bypass Graft 0.5 (1/191) 2.9%
TVR 11.0 (21/191) 16.3%
PTA 10.5 (20/191) 15.7%
Bypass Graft 0.5 (1/191) 2.9%
a
Percentage based on number of evaluable subjects for MAE. Subjects will be considered unevaluable for MAE at 12 months if a)
the subject withdrew before 330 days without having MAE events or b) the subject was lost to follow-up before 330 days without
having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death occurred after 30 days and
before 330 days without having MAE events
b
Lesions as reported by the Angiographic Core Laboratory
# Events (CEC adjudicated) 0
Time after initial procedure (days)
MAE 0 30 60 90 120 150 180 210 240 270 300 330 365
# Entered 196 196 195 194 193 188 188 183 178 172 171 170 167
# Censored 0 0 0 0 3 0 2 1 2 0 0 0 1 67
1 1 1 2 0 3 4 4 1 1 3 0
% Cumulative Incidence 0.0% 0.5% 1.0% 1.5% 2.6% 2.6% 4.1% 6.2% 8.4% 8.9% 9.4% 11.0% 11.0%
Standard Error 0.0% 0.5% 0.7% 0.9% 1.1% 1.1% 1.4% 1.7% 2.0% 2.1% 2.1% 2.3% 2.3%
8 Instructions for Use English
Figure 7. Cumulative Survival Distribution Function Estimate Over 365 Days Period for Subjects with MAE
6.1.4. Study Results: Effectiveness Endpoint
a
Percentage based on number of subjects who had available duplex data (for subjects with more than one duplex scan analysis the worse
case is counted)
b
Defined as: uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥50% as
documented by DUS peak systolic velocity ratio ≥2.0
Primary Effectiveness Endpoints % (m/n)
a
Exact One-
sided Lower
97.5% CI
Primary Patency
b
Rate at 12 Months 72.6 (127/175) 65.3%
Patency
# Risk1
# Censored
2
# Events
Kaplan- Meier Estimate3
Standard Error
1
Number of subjects at risk at the beginning of an interval.
2
Subjects are censored because their last follow-up has not reached the end of the time interval. Censored subjects will
include those who withdraw, are lost to follow-up or die.
3
Kaplan-Meier Estimate and Standard Error were calculated at the end of a time interval.
a
Percentage based on number of subjects who had available duplex data (for subjects with more than one duplex scan analysis the worse
case is counted)
b
Defined as: uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥50% as
documented by DUS peak systolic velocity ratio ≥2.4
Primary Effectiveness Endpoints % (m/n)
a
Exact One-
sided Lower
97.5% CI
Primary Patency
b
Rate at 12 Months 74.9 (131/175) 67.8%
The primary effectiveness endpoint is the primary patency rate at 12 months. Primary patency is defined as uninterrupted patency with 0 procedures performed
on or at the margins of the treated segment, with 0 restenosis ≥50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).
The primary patency rate at 12 months is summarized in Figure 8.
Figure 8. Primary Effectiveness Endpoint
Time after initial procedure (days)
0 - 90 91 - 180 181 - 270 271 - 360 361 - 390 >=391
175 175 173 172 159 137
0 0 0 0 0 127
0 2 1 13 22 10
100.0% 98.9% 98.3% 90.9% 78.3% 72.5%
0.0% 0.8% 1.0% 2.2% 3.1% 3.4%
Figure 9. Kaplan-Meier Estimates of Primary Patency over time
6.1.5. Additional Measures of Safety and Effectiveness
The primary patency rate for this study using the PSVR ≥2.4 is 74.9% (131/175) with an exact one-sided 97.5% lower CI of 67.8% (Figure 10).
Figure 10. Primary Effectiveness Endpoint with cut-off of PSVR ≥2.4
6.1.6. Patency vs. Lesion Length
Figure 11 presents a lesion length terciles analysis based on Complete SE primary patency outcome and analyzed using PSVR threshold of 2.0 as well as
using 2.4.
Instructions for Use English 9
Figure 11. Primary Patency to 12 Months as a Function of Lesion Length
Total N = 196
Total Lesionsa = 213
Lesion Length Terciles
Lower
(N = 65 Patients
N= 71 Lesions)
Mid
(N = 65 Patients
N= 74 Lesions)
Upper
(N = 66 Patients
N= 68 Lesions)
Pre-Procedure Lesion Length (mm)
n
71
73
65
Mean ± SD
27.31 ± 10.13
53.21 ± 13.75
105.65 ± 30.15
Median
28.0
55.0
99.1
Min, Max
5.0, 40.3
11.4, 73.4
37.3, 228.0
Primary Eectiveness Endpoint
Primary Patency (PSVR ≥ 2.0)
b,c
Rate at 12 Months
83.6% (46/55)
68.9% (42/61)
66.1% (39/59)
Primary Patency (PSVR ≥ 2.4)
b,c
Rate at 12 Months
83.6% (46/55)
70.5% (43/61)
71.2% (42/59)
a
Lesions as reported by the Angiographic Core Laboratory. In subjects with more than one lesion the longest lesion was used for
categorizing them into lesion length terciles.
b
Percentage based on number of subjects who had available duplex data (for subjects with more than one duplex scan analysis
the worse case is counted)
c
Defined as: uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis
>=50% as documented by DUS peak systolic velocity ratio >=2.0 or >=2.4
N = Intent-To-Treat Population
Note: Site, CEC, Duplex and Angiographic Core Laboratory Reported Table
Secondary Endpoints % (m/n) Exact Two-sided 95% CI
MAE at 30 Days
a
0.5 (1/196) (0.0%, 2.8%)
MAE at 6 Monthsb 4.1 (8/194) (1.8%, 8.0%)
Device Success
c
90.0 (189/210) (85.1%, 93.7%)
Lesion Success
d
90.0 (190/211) (85.2%, 93.7%)
Procedure Success
e
89.1 (172/193) (83.8%, 93.1%)
Assisted Primary Patency Rate at 12 Months
f
78.3 (137/175) (71.4%, 84.2%)
Secondary Patency Rate at 12 Months
g
78.9 (138/175) (72.1%, 84.7%)
Change in Quality of Life:
Improvement in Rutherford Class by ≥1 Category at 12 Months
h
90.9 (160/176) (85.7%, 94.7%)
Increase in ABI or TBI ≥0.15 at 12 Months
h
64.5 (107/166) (56.7%, 71.7%)
Decline in Rutherford Class ≥1 Category at 30 Days
h
89.7 (174/194) (84.5%, 93.6%)
Stent integrity at 12 Months
i
95.8 (181/189) (91.8%, 98.2%)
Clinically-driven TLR at 12 Months
j
8.4 (16/191) (4.9%, 13.2%)
a
Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE at 30 days if a) withdrawn before 25 days without having MAE events
or b) lost to follow-up before 25 days without having MAE events and had no contact thereafter
b
Percentage based on number of evaluable subjects for MAE. Subjects will be considered unevaluable for MAE at 6 months if a) the subject withdrew before 150 days without
having MAE events or b) the subject was lost to follow-up before 150 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated
death occurred after 30 days and before 150 days without having MAE events
c
Device success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned
d
Lesion success defined as angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard
percutaneous devices. Percentage based on number of lesions with available data
e
Procedure success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related MAE
prior to hospital discharge. Percentage based on number of subjects with available data (for subjects with more than one lesion stented the worse case is counted)
f
Defined as vessel patency resulting from a procedure performed in the treated segment to restore blood flow after restenosis. For patients with multiple TLR events, only the
earliest TLR will be considered for Assisted Primary Patency. Percentage based on number of subjects with available duplex data
g
Defined as vessel patency resulting from any procedure that restores patency. Percentage based on number of subjects with available duplex data. For patients with multiple
TLR events, any TLR will be considered for Secondary Patency.
h
Percentage based on number of subjects with available data at related time point
i
Percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up
j
Clinically-driven TLR is defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by:
a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI ≥0.15
N = Intent-To-Treat Population
Note: Site, CEC, Duplex and Angiographic Core Laboratory Reported Table
6.1.7. Secondary Endpoints and Results
As presented (Figure 12), the 30-day MAE rate was 0.5% (1/196). The device, lesion and procedure success rates were between 89-90%. The secondary
patency rate at 12 months was 78.9% (138/175). The clinically-driven target revascularization (TLR) rate at 12 months was 8.4% (16/191). Clinically-driven TLR
is defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by a
changed (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI ≥0.15.
There were 3 measures of Quality of Life observed at 12 months: Improvement in Rutherford Class by ≥1 category at 12 months was 90.9%; the increase in
ankle-brachial index/toebrachial index (ABI/TBI) of ≥0.15 at 12 months was 64.5%; and the decline in Rutherford Class ≥1 at 30 days was 89.7%.
Analyses of all flat-plate X-rays by the Vascore core laboratory indicated that there were 8 (4.2%) stent fractures observed at 12 months, and of those fractures,
7 were grade 1, 1 was grade 2, and 0 were grade 3, grade 4, or grade 5. Medtronic conducted an additional stent fracture analysis and determined that there
were zero fractures. For additional information, see Additional Stent Fracture Analysis (Section 6.1.7.1).
Figure 12. Secondary Endpoints
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