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General |
Study Status |
Completed |
Application Number / Requirement Number |
P120002 / PAS001 |
Date Original Protocol Accepted |
11/07/2012
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Date Current Protocol Accepted |
11/07/2012
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Study Name |
STROLL Post Approval Study
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Device Name |
SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
Sponsor Registry
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Comparison Group |
Historical Control
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Analysis Type |
Descriptive
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Study Population |
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
A non-randomized, multicenter, prospective, single- arm study.
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Study Population |
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.
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Sample Size |
39 sites in the United States. A total of evaluable subjects at 3 year follow-up.
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Key Study Endpoints |
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.
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Follow-up Visits and Length of Follow-up |
No new enrollments are planned for the post-approval study. 3 years following index procedure.
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
250
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Actual Number of Sites Enrolled |
39
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Patient Follow-up Rate |
90.9% (190/209) [209 = number of patients eligible for 3 year visit]
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Final 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)
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Final 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
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Study 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.
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Recommendations for Labeling 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.
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