INSTRUCTIONS FOR USE
Solitaire™ Platinum
Revascularization Device
DWGS71064-010 Rev. B (04/2019)
TABLE OF CONTENTS
Solitaire™ Platinum Revascularization Device
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Instructions for Use
Solitaire™ Platinum Revascularization Device
PRECAUTIONS
• The Solitaire™ Platinum Revascularization Device should only be used by physicians trained in interventional
neuroradiology and treatment of ischemic stroke.
• Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using
sucient shielding, reducing uoroscopy times, and modifying X-ray technical factors whenever possible.
• Carefully inspect the sterile package and the Solitaire™ Platinum Revascularization Device prior to use to verify that
neither has been damaged during shipment. Do not use kinked or damaged components.
• The Solitaire™ Platinum Revascularization Device is not to be used after the expiration date imprinted on the product
label.
• Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications,
contraindications, warnings, precautions, and instructions for use.
• Initiate mechanical thrombectomy treatment as soon as possible.
• For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset.
• For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for
assessing core infarct size.
DESCRIPTION
The Solitaire™ Platinum Revascularization Device is designed to restore blood ow by removing thrombus in
patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the
neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the
vertebral arteries.
Figure 1:
Solitaire™ Platinum Revascularization Device
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3
1
2
INDICATIONS
1. The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood ow in the neurovasculature
by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent,
proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have rst received intravenous
tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of
symptom onset.
2. The Solitaire™ Platinum Revascularization Device is indicated to restore blood ow by removing thrombus from a
large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are
ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
3. The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood ow in the neurovasculature
by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent,
proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery
(MCA)-M1 segments with smaller core infarcts (<70 cc by CTA or MRA, <25 cc by MR-DWI). Endovascular therapy
with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous
tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
CONTRAINDICATIONS
Use of the Solitaire™ Platinum Revascularization Device is contraindicated under these circumstances.
• Patients with known hypersensitivity to nickel-titanium.
• Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the
Solitaire™ Platinum Revascularization Device.
• Patients with angiographic evidence of carotid dissection.
POTENTIAL COMPLICATIONS
Possible complications include, but are not limited to the following:
• Adverse reaction to antiplatelet/ anticoagulation
agents or contrast media
• Air Embolism
• Allergic reactions • Perforation or dissection of the vessel
• Arteriovenous Fistula • Persistent neurological decits
• Brain Edema • Post procedure bleeding
• Change in mental status • Pseudo aneurysm formation
• Device(s) deformation, collapse, fracture or
malfunction
• Distal embolization including to a previously
uninvolved territory
• Hematoma and hemorrhage at puncture site
• Infection • Thrombosis (acute and subacute)
• Inammation • Vascular occlusion
• Intracranial Hemorrhage • Vasoconstriction (Vasospasm)
• Ischemia
• Neurologic deterioration including stroke
progression, stroke in new vascular territory, and
death
• The risk of complication of radiation exposure
(e.g., alopecia, burns ranging in severity from
skin reddening to ulcers, cataracts, and delayed
neoplasia) increases as the procedure time and the
number of procedures increase
WARNINGS ALL INDICATIONS
1. Proximal marker
2. Distal markers
3. Introducer sheath
4. Push wire
5. Fluorosafe marker
Model
Recommended Vessel
Diameter1 (mm)
min. max. (mm) (inch) (cm) (mm) (mm) (mm) (cm) Distal Prox. (mm)
SFR3-4-20-05
SFR3-4-20-10
SFR3-4-40-10
SFR3-6-20-10
SFR3-6-24-06
SFR3-6-40-10
1
Select a Solitaire™ Platinum Revascularization Device based on the sizing recommendations in Table 1 and based on the smallest vessel diameter at thrombus site.
2
Select a Solitaire™ Platinum Revascularization Device usable length that is at least as long as the length of the thrombus.
2.0 4.0 0.5 0.021 180 4.0 20.0 31.0 <130 3 1 5
2.0 4.0 0.5 0.021 180 4.0 20.0 31.0 <130 3 1 10
2.0 4.0 0.5 0.021 180 4.0 40.0 50.0 <130 3 1 10
2.0 5.5 0.7 0.027 180 6.0 20.0 31.0 <130 4 1 10
2.0 5.5 0.7 0.027 180 6.0 24.0 37.0 <130 4 1 6
2.0 5.5 0.7 0.027 180 6.0 40.0 47.0 <130 4 1 10
A. Stent diameter
B. Stent length
C. Length from distal marker to proximal marker
D. Length from distal tip to uorosafe marker
E. Marker to marker length
Solitaire™ Platinum Revascularization Device:
Product Specifications and Recommended Sizing Guidelines
Minimum Microcatheter ID
Push Wire
Length
• The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard
medical practice.
Table 1.
Stent
Diameter
Stent Length
2
Proximal
Marker to
Distal Marker
Length
Length from
Distal tip to
fluorosafe
marker
Radiopaque
Markers
Radiopaque
Stent Markers
Spacing
3
WARNINGS ALL INDICATIONS
• Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Do not cause delays
in this therapy.
• Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset
(IV t-PA use beyond 3 hours is not approved in the United States).
• Do not torque the Solitaire™ Platinum Revascularization Device.
• For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ Platinum
Revascularization Devices.
• For device safety, do not use each Solitaire™ Platinum Revascularization Device for more than three ow
restoration recoveries.
• For each new Solitaire™ Platinum Revascularization Device, use a new microcatheter.
• Solitaire™ Platinum Revascularization Device does not allow for electrolytic detachment.
• To prevent device separation:
• Do not oversize device.
• Do not recover (i.e. pull back) the device when encountering excessive resistance. Instead, resheath
the device with the microcatheter and then remove the entire system under aspiration. If resistance is
encountered during resheathing, discontinue and remove the entire system under aspiration.
• Do not treat patients with known stenosis proximal to the thrombus site.
• This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and
re-sterilization increase the risks of patient infection and compromised device performance.
WARNINGS INDICATION 1 & 3 ONLY
• The safety and eectiveness has not been established for the Solitaire™ Platinum device to reduce disability in
patients with the following:
• Posterior circulation occlusions
• More distal occlusions in the anterior circulation
• Large core infarct (ASPECTS ≤7)
CLINICIAN USE INFORMATION
Materials Required
The following parts are required to use the Solitaire™ Platinum Revascularization Device:
• Solitaire™ Platinum Revascularization Device with the SFR3-4-20-05, SFR3-4-20-10 and SFR3-4-40-10 reference
numbers should be introduced only through a size “18” microcatheter with a minimum inside diameter of 0.021
inches.
• Solitaire™ Platinum Revascularization Device with the SFR3-6-20-10, SFR3-6-24-06 and SFR3-6-40-10 reference
numbers should be introduced only through a microcatheter with a minimum inside diameter of 0.027 inches.
Compatibility testing has been performed with the Rebar™ microcatheter. Refer to the instructions supplied with all
interventional devices and materials to be used in conjunction with the Solitaire™ Platinum Revascularization Device for
their intended uses, contraindications and potential complications.
Other accessories for performing a procedure and NOT supplied; to be selected based on the physician’s experience
and preferences:
• Minimum 5F guide catheter
(NOTE: Users should select a guide catheter with appropriate support to deliver interventional devices. For a guide
catheter a minimum inside diameter 0.061’’ is recommended. For a balloon guide catheter ensure to use 8-9F with
minimum inside diameter 0.075”)
• Microcatheter (refer to Table 1)
• Guidewire
• Aspiration Device (60 cc syringe or aspiration pump/system, such as Riptide™ Aspiration System)
NOTE: The Riptide™ Aspiration System has been bench tested with the Solitaire™ Revascularization Device as
an aspiration device during retrieval to the guide catheter. Other comparable aspiration pump systems have
been reported in clinical literature, although these devices have not been specically tested with the Solitaire™
Revascularization Devices.
• Saline solution/heparin-saline continuous ush set
• Rotating Hemostasis Valve (RHV)
• Infusion stand
• Femoral arterial lock
PREPARATION AND PROCEDURE
Preparation
1. Administer anti-coagulation and anti-platelet medications per standard institutional guidelines.
2. Aided by angiographic radiography, determine the location and size of the area to be revascularized.
3. Select a Solitaire™ Platinum Revascularization Device per Table 1.
4. To achieve optimal performance of the Solitaire™ Platinum Revascularization Device and to reduce the risk of
thromboembolic complications, maintain continuous ushing action between a) the femoral arterial sheath and
the guide catheter, b) the microcatheter and the guide catheter and c) the microcatheter and the push wire and the
Solitaire™ Platinum Revascularization Device. Check all connections to make sure that during the continuous ush no
air enters the guide catheter or the microcatheter.
5. Position a suitable guide catheter as close to thrombus site as possible employing a standard method. The guide
catheter should be appropriately sized to retrieve clot if so desired in subsequent steps. Connect a RHV to the tting
of the guide catheter, and then connect a tube to the continuous ush.
6. With the aid of Table 1, select a microcatheter suitable for advancing the Solitaire™ Platinum Revascularization
Device.
7. Connect a second RHV to the tting of the microcatheter and then connect a tube to the continuous ush.
8. Set the ush rate per standard institutional guidelines.
9. With the aid of a suitable guide wire, advance the microcatheter until the end of the microcatheter is positioned
distal to the thrombus so that the usable length portion of the Solitaire™ Platinum Revascularization Device will
extend past each side of the thrombus in the vessel when fully deployed. Tighten the RHV around the microcatheter.
Delivering the Solitaire™ Platinum Revascularization Device
10. Insert the distal end of the introducer sheath partially into the RHV connected to the microcatheter. Tighten the RHV
and verify that uid exits the proximal end of the introducer sheath.
11. Loosen the RHV and advance the introducer sheath until it is rmly seated in the hub of the microcatheter. Tighten
the RHV around the introducer sheath to prevent back ow of blood, but not so tight as to damage the Solitaire™
Platinum Revascularization Device during its introduction into the microcatheter. Conrm that there are no air
bubbles trapped anywhere in the system.
12. Transfer the Solitaire™ Platinum Revascularization Device into the microcatheter by advancing the push wire in a
smooth, continuous manner. Once the exible portion of the push wire has entered the microcatheter shaft, loosen
the RHV and remove the introducer sheath over the proximal end of the push wire. Once completed, tighten the RHV
around the push wire. Leaving the introducer sheath in place will interrupt normal infusion of ushing solution and
allow back ow of blood into the microcatheter.
13. Visually verify that the ushing solution is infusing normally. Once conrmed, loosen the RHV to advance the push
wire.
14. Once the Solitaire™ Platinum Revascularization Device has been advanced to the uorosafe marker band
begin uoroscopic imaging. With the aid of uoroscopic monitoring, carefully advance the Solitaire™ Platinum
Revascularization Device until its distal markers line up at the end of the microcatheter. The Solitaire™ Platinum
Revascularization Device should be positioned such that the usable length portion of the device will extend past each
side of the thrombus in the vessel when the device is fully deployed.
WARNING ALL INDICATIONS
• If excessive resistance is encountered during the delivery of the Solitaire™ Platinum Revascularization Device,
discontinue the delivery and identify the cause of the resistance. Advancement of the Solitaire™ Platinum
Revascularizaton Device against resistance may result in device damage and/or patient injury.
Deploying the Solitaire™ Platinum Revascularization Device
15. Loosen the RHV around the microcatheter. To deploy the Solitaire™ Platinum Revascularization Device, x the push
wire to maintain the position of the device while carefully withdrawing the microcatheter in the proximal direction.
Figure 2:
Solitaire™ Platinum Revascularization Device Deployment
16. Retract the microcatheter until it is just proximal to the proximal marker of the Solitaire™ Platinum Revascularization
Device. Tighten the RHV to prevent any movement of the push wire. The usable length of the deployed Solitaire™
device should extend past each side of the thrombus.
17. Tighten the RHV around the microcatheter. Angiographically assess the revascularization status of the treated vessel.
Revascularization Device Recovery
18. If using balloon guide catheter, inate guide catheter balloon to occlude vessel as specied in Balloon Guide Catheter
labeling.
19. Ensure the proximal marker on the Solitaire™ Platinum Revascularization Device is within the microcatheter as in
Figure 3 below. Loosen the RHV around the microcatheter enough for movement while still maintaining a seal.
Figure 3:
Solitaire™ Platinum Revascularization Device Recovery Position
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20. To retrieve thrombus, slowly withdraw the microcatheter and the Solitaire™ Platinum Revascularization Device as
a unit to the guide catheter tip while applying aspiration to the guide catheter with the aspiration device. Never
advance the deployed Solitaire™ Platinum Revascularization Device distally.
NOTE: Ensure microcatheter covers proximal marker.
21. Apply vigorous aspiration to the guide catheter using the aspiration device and recover the Solitaire™ Platinum
Revascularization Device and microcatheter inside guide catheter. Continue aspirating guide catheter until the
Solitaire™ Platinum Revascularization Device and microcatheter are nearly withdrawn from the guide catheter.
NOTE: If withdrawal into the guide catheter is dicult, deate balloon (if using balloon guide catheter) and then
simultaneously withdraw guide catheter, microcatheter and Solitaire™ Platinum Revascularization Device as a unit
through the sheath while maintaining aspiration. Remove sheath if necessary.
WARNINGS ALL INDICATIONS
• If excessive resistance is encountered during recovery of the Solitaire™ Platinum Revascularization Device,
discontinue the recovery and identify the cause of the resistance.
• For vessel safety, do not perform more than three recovery attempts in the same vessel using the Solitaire™
Platinum Revascularization Device.
22. Open the guide catheter RHV to allow the microcatheter and the Solitaire™ Platinum Revascularization Device to exit
without resistance. Use care to avoid interaction with the site of the intervention and to prevent air from entering
the system.
23. Aspirate the guide catheter to ensure the guide catheter is clear of any thrombus material.
24. Deate guide catheter balloon if using balloon guide catheter.
25. If additional ow restoration attempts are desired with:
a. A new Solitaire™ Platinum Revascularization Device, then:
i. Repeat the steps described above starting with the “Preparation” section.
b. The same Solitaire™ Platinum Revascularization Device, then:
i. Clean the device with saline solution.
NOTE: Do not use solvents or autoclave.
ii. Carefully inspect the device for damage. If there is any damage, do not use the device and use a new
Solitaire™ Platinum Revascularization Device for subsequent ow restoration attempts following the
steps described above starting with the “Preparation” section. Use of a damaged device could result in
additional device damage or patient injury.
WARNING ALL INDICATIONS
• For device safety, do not use each Solitaire™ Platinum Revascularization Device for more than three ow
restoration recoveries.
Solitaire™ Platinum Revascularization Device Re-Sheathing
If resheathing of the Solitaire™ Platinum Revascularization Device is necessary (e.g. repositioning), follow
these steps:
WARNING ALL INDICATIONS
• Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris.
• Do not advance the microcatheter against any resistance.
• Do not reposition more than two times.
1. Loosen the RHV around the microcatheter and around the push wire. With the aid of uoroscopic monitoring, hold
the push wire rmly in its position to prevent the Solitaire™ Platinum Revascularization Device from moving.
2. Carefully re-sheath the Solitaire™ Platinum Revascularization Device by advancing the microcatheter over the
Solitaire™ Platinum Device until the distal markers of the Solitaire™ Platinum Device line up at the end of the
microcatheter as illustrated in Figure 4 below.
If significant resistance is encountered during the re-sheathing process, stop immediately and proceed to
the section above entitled “Revascularization Device Recovery”.
Figure 4:
Solitaire™ Platinum Revascularization Device Re-sheathing
HOW SUPPLIED
The Solitaire™ Platinum Revascularization Device is provided sterile for single patient use only.
Sterile: This device is sterilized with Ethylene Oxide. Non-pyrogenic.
Contents: One (1) Solitaire™ Platinum Revascularization Device.
Storage: Store product in a dry, cool place.
SAFETY AND EFFECTIVENESS INFORMATION INDICATION 1
SWIFT PRIME Clinical Study
SWIFT PRIME (Solitaire™ FR or Solitaire™ 2 With the Intention For Thrombectomy as Primary Endovascular
Treatment for Acute Ischemic Stroke) is a global, multicenter, two-arm, prospective, randomized, open,
blinded endpoint (PROBE) clinical study comparing neurological disability outcomes (dened by mRS) in
Acute Ischemic Stroke (AIS) patients who are treated with either IV t-PA alone or IV t-PA in combination with
Solitaire™ FR or Solitaire™ 2 mechanical thrombectomy intervention. Subjects receiving IV t-PA within 4.5
hours of symptom onset were randomized 1:1 to mechanical thrombectomy with Solitaire™ within 6 hours
of onset, or to continuation with IV t-PA alone. Within this group, the Analysis cohort was dened as those
subjects who were administered IV t-PA within 3 hours of symptom onset.
Inclusion Criteria
Subjects were considered eligible for the study if they satised all of the following inclusion criteria:
• Subject or subject’s legally authorized representative has signed and dated an Informed Consent Form
• Age 18 – 80
• Clinical signs consistent with acute ischemic stroke
• Pre-stroke Modied Rankin Score less than or equal to 1
• National Institute of Health Stroke Scale (NIHSS) score of at least 8 and less than 30 at the time of randomization
• Initiation of IV t-PA within 4.5 hours of onset of stroke symptoms
• Thrombolysis in Cerebral Infarction (TICI) 0 to 1 ow in the intracranial internal carotid artery, M1 segment of the
MCA, or carotid terminus conrmed by CT or MR angiography that is accessible to the Solitaire™ FR or Solitaire™
2 device
• Subject is able to be treated within 6 hours of stroke symptoms onset and within 1.5 hours from CTA or MRA to
groin puncture
• Subject is willing to conduct follow-up visits
Exclusion Criteria
Subjects were considered ineligible for study participation if they met any of the following exclusion criteria:
• Subject who is contraindicated to IV t-PA as per local national guidelines
• Females who are pregnant or lactating
• Rapid neurological improvement prior to randomization suggesting resolution of signs/symptoms of stroke
• Known serious sensitivity to radiographic contrast agents
• Known sensitivity to Nickel, Titanium metals or their alloys
• Current participation in another investigational drug or device study
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deciency
• Renal failure as dened by a serum creatinine greater than 2.0 mg/dl (or 176.8 µmol/l) or Glomerular Filtration
Rate [GFR] less than 30
• Requires hemodialysis or peritoneal dialysis, or who have contraindication to an angiogram
• Life expectancy less than 90 days
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
• Suspicion of aortic dissection
• Co-morbid disease or condition that would confound the neurological and functional evaluations or compromise
survival or ability to complete follow-up assessments
• Currently uses or has a recent history of illicit drug(s) or abuses alcohol
• Known history of arterial tortuosity, pre-existing stent, and/or other arterial disease which would prevent the
device from reaching the target vessel and/or preclude safe recovery of the device
• Additionally, subjects were also considered ineligible for study participation if they met any of the following
imaging exclusion criteria:
• CT or MRI evidence of hemorrhage on presentation, mass eect or intracranial tumor (except small
meningioma), cerebral vasculitis, basilar artery (BA) occlusion or posterior cerebral artery (PCA) occlusion,
carotid dissection, or complete cervical carotid occlusion requiring stenting at the time of the index
procedure
• CT showing hypodensity or MRI showing hyperintensity involving greater than 1/3 of the middle cerebral
artery (MCA) territory (or in other territories, >100 cc of tissue) on presentation
• Baseline non-contrast CT or DWI MRI evidence of a moderate/large core dened as extensive early
ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) less than 6. Patients enrolled under
RAPID were excluded based on the following:
a) MRI- or CT-assessed core infarct lesion greater than 50 cc; or
b) Severe hypoperfusion lesion (10 sec or more Tmax lesion larger than 100 cc; or
c) Ischemic penumbra < 15 cc and mismatch ratio ≤1.8.
• Evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical
thrombectomy intervention
5
Study Endpoints
The primary eectiveness endpoint of the study is 90-day global disability assessed via the blinded evaluation of modied
Rankin Scale (mRS). Secondary clinical ecacy endpoints of the study are:
• Death due to any cause at 90 days.
• Functional independence as dened by mRS score ≤ 2 at 90 days.
• Change in NIHSS score at 27 ± 6 hours post randomization.
The secondary technical ecacy endpoints of the study are:
• Volume of cerebral infarction as measured by a CT or MRI scan at 27 ± 6 hours post randomization.
• Reperfusion measured by reperfusion ratio on CT or MRI scan 27 ± 6 hours post randomization.
• Arterial revascularization measured by TICI 2b or 3 following device use.
• Correlation of RAPID-assessed core infarct volume with 27 ± 6 hours post randomization stroke infarction in
subjects who achieved TICI 2b-3 reperfusion without intracranial hemorrhage.
Results
A total of 196 subjects were randomized into the SWIFT PRIME Study (98 in each group). The SWIFT PRIME study allowed
IV t-PA use beyond 3 hours, although IV t-PA is not approved in the United States beyond 3 hours. Patients treated with
IV-tPA beyond 3 hours did not factor strongly in the evaluation of the Solitaire™ 2 revascularization device and have been
excluded from the analyses. The resulting Analysis Cohort consists of 161 subjects (84 in the IV t-PA plus Solitaire™ group
and 77 with IV t-PA only). Additionally, 17 subjects in the IV t-PA plus Solitaire™ group were excluded from the primary and
secondary ecacy endpoint analyses. These 17 subjects either received carotid stenting and/or angioplasty or were treated
in a manner inconsistent with the Solitaire™ Instructions for Use. Therefore, the primary and secondary ecacy endpoint
analyses cohort consists of 144 subjects.
The proportion of patients functionally independent (mRS 0-2) at the 90-day visit was higher in the IV t-PA plus Solitaire™
device group. A summary of the subject disposition is presented below.
Table 2. Summary of Subject Disposition (Analysis Cohort)
Subject Disposition IV t-PA Only IV t-PA + Solitaire™ Overall
Attended 90 day visit 63/77 (81.8%) 60/67 (89.6%) 123/144 (85.4%)
Died prior to 90 day visit 10/77 (13.0%) 6/67 (9.0%) 16/144(11.1%)
Early Terminated
Subject Lost to Follow-Up 3/77 (3.9%) 0/67 (0.0%) 3/144 (2.1%)
Subject Withdrew Consent 1/77 (1.3%) 1/67 (1.5%) 2/144 (1.4%)
Investigator Withdrew the Subject 0/77 (0.0%) 0/67 (0.0%) 0/144 (0.0%)
Total 77 (100.0%) 67 (100.0%) 144 (100.0%)
Standard summary statistics were calculated for all study variables and subject data were analyzed according to the group
to which they were randomized. For continuous variables, statistics included means, standard deviations, medians and
ranges. Categorical variables were summarized in frequency distributions.
For the primary ecacy endpoint, statistical signicance was declared using bounds predened in the group sequential
analysis plan, which accounts for multiplicity due to interim analyses. Elsewhere, one-sided statistical tests having p-values
less than 0.025 were deemed signicant while two-sided tests having p-values less than 0.05 were deemed signicant.
For adverse event reporting, the primary analysis is based on subject counts, not event counts. Both subject counts and
event counts are presented in tabular summaries of results.
NOTE: The SFR3-4-20-05, SFR3-4-20-10, SFR3-4-40-10, SFR3-6-20-10, SFR3-6-24-06 and SFR3-6-40-10 models were not
evaluated as part of the SWIFT PRIME study.
Table 3. Primary Effectiveness Endpoint (Analysis Cohort)
mRS Score at 90 days IV t-PA Only* IV t-PA + Solitaire™ p-value
0.0007
0 7.9% (6/76) 16.4% (11/67)
1 11.8% (9/76) 31.3% (21/67)
2 17.1% (13/76) 14.9% (10/67)
3 18.4% (14/76) 11.9% (8/67)
4 18.4% (14/76) 13.4% (9/67)
5/6 26.3% (20/76) 11.9% (8/67)
Missing data at 90-day was imputed using LOCF (except baseline data not used)
*One subject from the IV t-PA only group withdrew consent 27 hours post randomization. No 90 day mRS Score was available for this subject.
0 1 2 3 4 5 & 6
Solitaire™ + IV tPA (N =
67)
IV tPA (N=76*)
81612
*
One subject from the IV t-PA only group withdrew consent 27 hours
post randomiza�on. No 90 day mRS Score was available for this subject.
31
17
Pa�ents (%)
15
1218132612
18
Figure 5: Modified Rankin Shift at 90 days (Analysis Cohort)
Table 4. Secondary Clinical Efficacy Endpoints (Analysis Cohort)
Secondary Clinical Efficacy
Endpoint
IV t-PA Only*
IV t-PA +
Solitaire™
Mortality at 90 days 10/76 (13.2%) 6/67 (9.0%) 0.65 (0.22-1.89) 0.596
Functional Independence (mRS
0-2) at 90 days
28/76 (36.8%) 42/67 (62.7%) 2.88 (1.46-5.68) 0.003**
Odds Ratio/
Difference
[95% CI]
p-value
Change in NIHSS at 27 hours Post randomization
N 76 66 <0.001**
Mean ± SD -4.3 ± 6.4 -9.9 ± 7.2 -5.6 (-7.9, -3.3)
Median -3.0 -9.5
(min, max) (-24.0, 9.0) (-27.0,10.0)
*One subject from the IV t-PA only group withdrew consent 27 hours post randomization. No secondary clinical ecacy endpoints were available for this subject.
**These p-values are for informative purposes only. Based on the pre-dened hierarchical testing of the secondary endpoints, these particular endpoints were not
achieved.
Table 5. Secondary Technical Efficacy Endpoints (Analysis Cohort)
Secondary Technical
Efficacy Endpoint
IV t-PA Only IV t-PA + Solitaire™
Infarct Volume at 27 hours Post-Randomization (cc)**
N 77 66
Mean ± SD 68.9 ± 75.5 51.1 ± 86.1 N/A*
Median 46.5 19.2
(min, max) (0.0, 406.6) (0.0,530.5)
Reperfusion Ratio at 27 hours Post-Randomization**
N 44 45
Mean ± SD 61.6 ± 56.1 87.9 ± 37.2 N/A*
Median 84.0 100.0
(min, max) (-200.0, 100.0) (-94.0,100.0)
TICI 2b-3 Following Device Use**
% (n/N) N/A 90.2% (55/61) N/A
*Wilcoxon rank-sum test due to non-normality of data.
** Per Core Laboratory assessed data
Difference
[95% CI]
Table 6. Primary Safety Endpoints (Analysis Cohort)
Safety Endpoint IV t-PA Only IV t-PA + Solitaire™ Odds Ratio
Primary Safety Variables
Any serious adverse event* 33.8% (26/77) 31.0% (26/84) 0.88 (0.45-1.70)
Symptomatic ICH at 27
hours**
NA denotes not applicable
*Per Clinical Events Committee adjudication
**Per Core Laboratory assessed data
3.9% (3/77) 0.0% (0/84) NA
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