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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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SCENT Post-Approval Study


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General
Study Status Completed
Application Number /
Requirement Number
P170024 / PAS001
Date Original Protocol Accepted 07/13/2018
Date Current Protocol Accepted  
Study Name SCENT Post-Approval Study
Device Name Surpass Streamline Flow Diverter
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The objective of the trial is to determine the long-term safety and effectiveness of the Surpass Flow Diverter in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus.
Study Population Subjects with a large or giant intracranial aneurysm in the internal carotid artery up to the terminus
Sample Size 213 Subjects Enrolled
Key Study Endpoints The primary efficacy endpoint as determined by the angiographic core lab, is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (defined as = 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment at the target aneurysm at the 12 month follow-up visit. Safety success is achieved with a primary safety event rate significantly less than 20%
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 236 subjects were enrolled in the SCENT Post-Approval Study; 213 subjects (90.3%) received treatment and 23 subjects (9.7%) were Enrolled but not Treated (ENT). Of the 213 subjects who completed the study procedure, 180 comprise the modified Intent to Treat (mITT) cohort and 33 comprise the Roll-in cohort.
Actual Number of Sites Enrolled 26 sites, including 25 US sites and 1 international site
Patient Follow-up Rate The follow-up rates for mITT cohort at 1-yr, 2-yr, 3-yr, 4-yr, and 5-yr follow-up visits are 96.5%, 97.6%, 89.9%, 97.9% and 96.7% respectively.
The follow-up rates for Roll-in cohort at 1-yr, 2-yr, 3-yr, 4-yr, and 5-yr follow-up visits are 100%, 100%, 89.3%, 100% and 100% respectively.
Final Safety Findings Summary of primary safety and efficacy endpoints at 12 months follow-up
The primary safety endpoint is the rate of neurological death or major ipsilateral stroke through 12-months. The primary safety rate in the SCENT Post-Approval Study mITT population was 11.1% [95% CI of (6.92% - 16.64%)], with the upper limit being less than the performance goal of 20%, rejecting the null hypothesis at p = 0.001.
The primary efficacy endpoint is 100% target intracranial aneurysm occlusion (Raymond Class 1) without clinically significant stenosis (defined as = 50% stenosis of the parent artery) of the parent artery based on core lab evaluation at 12-months follow up angiogram and without any subsequent treatment at the target intracranial aneurysm at the 12-months follow up visit. The primary effectiveness rate in the SCENT Post-Approval Study mITT population was 62.8% [95% CI of (55.3% - 69.9%)], rejecting the null hypothesis at p = 0.001.

Summary of long-term safety and efficacy endpoints for 12-60 months follow-up
Description of the mITT cohort:
Neurological Death: N=5, no change from the 12-months follow-up during the long-term follow-up; note, subject 28-007 died of a neurological death at 1849 days post-procedure, which is outside of the 5-year follow-up cut-off date which was defined as 1825 days.
Clinical Events Committee (CEC) Adjudicated new or worsening major ipsilateral stroke: 11.1% (20/180) at 12-months and 21, 22, 23, and 23 subjects at 24, 36, 48, and 60 months respectively.
Aneurysm Rupture: four subjects (2.2%; 4/180) at 12-month; no change from the 12-months follow-up during the long-term follow-up.
Incidence of retreatment: 0.6% (1/180) at 12-months, 1.1% (2/180) at 24 months, and 2.8% (5/180) at 36 months. No additional retreatment occurred through 60 months.
Unchanged or improved functional outcome scores (as measured by modified Rankin Scale (mRS) score compared to baseline): 82.8% (111/134) at 36 months and 80.7% (96/119) at 60 months.
Worsening in mRS: 10.0% (18/180) at 12-months timepoint; at 36-months, the rate of change compared to baseline was 10.4% (14/134); at 60-months, the rate of change was 9.2% (11/119).

Description of the Roll-in cohort:
Neurological Death: N=3, per CEC adjudication, 1 neurological death was reported at 12 months, 1 neurological death occurred at 36 months, and 1 additional neurological death occurred at 60 months. No change in the number of neurological death since the last report.
CEC Adjudicated new or worsening major ipsilateral stroke: 4, 4, 4, 5, and 5 at 12, 24, 36, 48 and 60 months, respectively.
Aneurysm Rupture: No subject (0/0) in the Roll-In cohort experienced aneurysm rupture at any long-term follow-up time point.
Incidence of retreatment: 0, 0, 1, 1, 1 at 12, 24, 36, 48 and 60 months, respectively.
Unchanged or improved functional outcome scores (as measured by mRS compared to baseline): 88.0% (22/25) at 36 months and 85.7% (18/21) at 60 months, compared to the 78.8% (26/33) measured at 12-months.
Worsening in mRS: at 12-months timepoint was 15.2% (5/33); at 36 months, the rate of worsening was (8%; 2/25); at 60 months, the rate of change was 9.5% (2/21).

Study Strengths & Weaknesses Strength: A prospective and long-term study with follow-up rate for mITT and Roll-in cohorts at about 90%.
Weaknesses: Single-arm study not controlling for confounding factors. Gender distribution is skewed. The majority of study subjects were female (91.1%) and male subjects were under represented, which leads to a limitation in the generalizability of the study results.
Recommendations for Labeling Changes yes


SCENT Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/11/2019 01/10/2019 On Time
one year report 07/13/2019 07/03/2019 On Time
18 month report 01/11/2020 01/13/2020 Overdue/Received
two year report 07/12/2020 07/13/2020 Overdue/Received
final report 07/12/2021 07/12/2021 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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