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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110040 / PAS001 |
| Date Original Protocol Accepted |
09/19/2013
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| Date Current Protocol Accepted |
09/19/2013
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| Study Name |
Complete SE SFA Long Term Study
|
| Device Name |
MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM
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| Clinical Trial Number(s) |
NCT00814970
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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.
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| 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
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| Key Study Endpoints |
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.
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| Follow-up Visits and Length of Follow-up |
3 years post treatment
yearly
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
196
187 subjects were available at 12 months for follow-up though 36 month post procedure
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| Actual Number of Sites Enrolled |
28 (23 in the United Sates and 5 in Belgium and Germany)
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| Patient Follow-up Rate |
84.5% (131/151) at 36 months
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| Final 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.
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| Study 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.
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| Recommendations for Labeling 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.
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