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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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Complete SE SFA Long Term Study


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General
Application Number P110040 / PAS001
Current Plan Approved 09/19/2013
Study Name Complete SE SFA Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Study Objective

To evaluate the safety and effectiveness of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the superficial femoral (SFA) and/or proximal popliteal (PPA) in subjects with symptomatic peripheral artery disease (PAD).



Study Design

Extended follow-up of premarket cohort enrolled in a prospective, multicenter, single arm study.

There are no new enrollments.

Study Population Description All subjects with symptomatic ischemic PAD and above-the-knee lesions enrolled in the Complete SE SFA IDE study treated with the Complete SE Vascular stent.



Comparator: Performance goal (PG) of 35% event-free rate from acute death, amputation and TLRs.

Sample Size 196 subjects enrolled at 28 sites in the US, Germany and Belgium.



Assumptions for sample size calculation

¿ 30% attrition of original 196 IDE subjects at 36 month yields 137 PAS subjects

¿ PG: 35% event-free rate from acute death, amputation and TLRs

¿ CSE Stent true event-free rate from acute death, amputation and TLRs = 55.0%

¿ Study Power > 95%

¿ One-sided alpha error of 2.5%

¿ Sample size = 137 subjects evaluable for analysis based on the Exact test of the binomial distribution

Data Collection Primary endpoint: composite of freedom from acute death, amputation, and TLR events at 36 months.



Secondary endpoints evaluable at 24 and 36 months post implantation:

¿ All-cause mortality

¿ Stent integrity by flat plate x-rays

¿ Acute death, amputation and TLR event rates.
Follow-up Visits and Length of Follow-up 3 years post treatment

yearly

Final Study Results
Number of Patients 196



187 subjects were available at 12 months for follow-up though 36 month post procedure

Number of Sites 28 (23 in the United Sates and 5 in Belgium and Germany)
Follow-up Rate 84.5% (131/151) at 36 months
Safety Findings Primary Endpoint

The event free major adverse event (MAE) rate (composite of acute death, target lesion or vessel revascularization and target limb Amputation) at 36 months was 69.8%. The lower bound of the 97.5% confidence interval was 62% which is greater than pre-specified performance goal of 35%.



Secondary Endpoints

All-cause mortality at 24 and 36 months was 9.8% (18/184) [95% CI: 5.95%, 15.0%] and 14% (25/178)

[95% CI: 9.3%, 20.0%], respectively.

Stent Integrity at 24 and 36 months was 100% (159/159) [95% CI: 97.7%, 100%] and 100% (145/145) [95% CI: 97.5%, 100%], respectively.



Acute death, amputation and TLR events rate at 24 and 36 months was 22.5% (38/169) [95% CI:

16.4%, 29.5%] and 30.2% (48/159) [95% CI: 23.2%, 38.0%], respectively.

Strengths & Weaknesses The study involved formal hypotheses testing and it met its primary endpoint at 36 months.



Weakness

The PAS population comprised of 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 3-year long term results 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.


Complete SE SFA Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report-Final 10/20/2014 10/16/2014 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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