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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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STROLL Post Approval Study


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General
Application Number P120002 / PAS001
Current Plan Approved 11/07/2012
Study Name STROLL Post Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A non-randomized, multicenter, prospective, single- arm study.
Study Population Description Patients enrolled in the pivotal STROLL study who received the S.M.A.R.T. Nitinol Self-Expandable Stent. There is no pre-specified control group.
Sample Size 39 sites in the United States. A total of evaluable subjects at 3 year follow-up.
Data Collection Primary safety endpoint: A composite of all-cause death, amputation and target lesion revascularization (TLR) at 3 years.



Secondary Endpoints to be assessed at 2 and 3 years: (1) individual components of the composite safety endpoint including death, amputation and TLR, (2) Major adverse events (MAE) defined as: death, limb ischemia/amputation of target limb, TLR, or significant embolic events causing organ damage, (3) Stent fracture rate assessed by x-ray, (4) Clinically driven TLR, and target vessel revascularization (TVR), (5) Patency of the target vessel assessed by duplex ultrasound, (6) Limb ischemia assessed by Rutherford/Becker classification, and (7) Ankle brachial index.

Follow-up Visits and Length of Follow-up No new enrollments are planned for the post-approval study.

3 years following index procedure.

Final Study Results
Number of Patients 250
Number of Sites 39
Follow-up Rate 90.9% (190/209) [209 = number of patients eligible for 3 year visit]



Safety Findings At 3 years the composite endpoint death, index limb amputation, or clinically driven TLR was 31.5% (70/222, 1-sided upper bound 97.5% CI: 38.1), which is lower than the PG of 57% [the denominator 222

= number of patients with a major complication within 1080 days or patients with sufficient follow-up

(i.e. at least 1020 days for 1080-day visit)]. Thus the primary endpoint was met. KM estimate for the composite endpoint (secondary Analysis) was 30.3%.

MAE rate (overall) at 3 years: 31.5% (70/222) Death = 9.9% (22/222)

Index limb amputation rate = 0.9% (2/222) Clinically-driven TLR rate = 22.5% (50/222) Significant embolic event rate = 0.0% (0/222) Clinically-driven TVR rate (Overall) = 25.2% (56/222)

Effect Findings At 3 years the composite endpoint death, index limb amputation, or clinically driven TLR was 31.5% (70/222, 1-sided upper bound 97.5% CI: 38.1), which is lower than the PG of 57% [the denominator 222

= number of patients with a major complication within 1080 days or patients with sufficient follow-up

(i.e. at least 1020 days for 1080-day visit)]. Thus the primary endpoint was met. KM estimate for the composite endpoint (secondary Analysis) was 30.3%.

MAE rate (overall) at 3 years: 31.5% (70/222) Death = 9.9% (22/222)

Index limb amputation rate = 0.9% (2/222) Clinically-driven TLR rate = 22.5% (50/222) Significant embolic event rate = 0.0% (0/222) Clinically-driven TVR rate (Overall) = 25.2% (56/222

Strengths & Weaknesses The study achieved a high follow-up rate of about 91% at 3 year, with enough patients with 3 year data

for endpoint analysis. The primary safety endpoint was evaluated by a formal statistic and compared to a performance goal.



Weaknesses



The PAS population was the premarket cohort that was required to meet certain eligibility criteria. Thus, the study results may not reflect the device performance in routine clinical device.

Label Changes Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow ┬┐up visits etc.), results and study strengths and limitations.


STROLL Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
two year clinical report 12/10/2012 12/10/2012 On Time
Final Report 11/07/2013 08/26/2013 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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