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General |
Study Status |
Completed |
Application Number / Requirement Number |
P140002 / PAS001 |
Date Original Protocol Accepted |
05/22/2015
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Date Current Protocol Accepted |
 
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Study Name |
OSPREY Extended f/u study
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Device Name |
MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
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Clinical Trial Number(s) |
NCT01118117
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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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 |
To evaluate the long-term safety and effectiveness of the Misago stent at 36 months in the US cohort of the OSPREY pivotal study. This study is a multi-center, single arm, prospective continued follow-up of the OSPREY pivotal US study.
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Study Population |
US subjects implanted with the Misago stent from OSPREY pivotal study
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Sample Size |
All 198 remaining patients (15 patients exited due to death and 3 lost to follow-up) of the 216 OSPREY pivotal study US patients enrolled from 31 investigational sites. A minimum of 173 subjects at 36 months are required to provide >80% power assuming an underlying freedom from event proportion of at least 66% and two-sided 0.05 alpha.
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Key Study Endpoints |
Primary Endpoint Freedom from clinically driven TLR assessed at 36 months post-procedure Co-Primary Endpoint Freedom from clinically driven TLR assessed at 24 months post-procedure. Secondary Endpoints ¿X Freedom from the composite endpoint of acute death (within 30 days), amputation of the target limb, or clinically driven TLR assessed at 24 and 36 months post-procedure. ¿X Ankle-Brachial Index (ABI) change from 30 days through 36 months post-procedure for durability of results ¿X Rutherford sustained (without increase of one or more in the score) at 36 months post-procedure from 30 days post-procedure for durability of results ¿X Quality of Life Measurements: Quality of Life Survey (SF-36) and the Walking Impairment Questionnaire (WIQ) long-term sustainability at 24 months post-procedure through evaluation of the change from baseline and from 30 days. ¿X Evaluation of all AEs through 24 and 36 months post-procedure ¿X Device failure defined as the occurrence of either of the following through 36 months: − Malfunctions (when used in accordance with the IFU, but does not perform according to the IFU, Or − Stent fracture as evidenced by plain X-ray evaluation ¿X Device related complications through 36 months defined as any of the following: − Target lesion revascularization (TLR) of the treated limb − Amputation of treated limb − All-cause Mortality − Distal embolization − Thrombosis of target vessel − Arterial dissection /perforation/rupture/injury − Hemorrhage − Hypotension − Arterial spasm − Arteriovenous fistula − Arterial embolism/thrombosis/occlusion − Stent Fracture − Leg Pain/Claudication
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Follow-up Visits and Length of Follow-up |
36 months post-implantation Frequency of Follow-up Assessments Annual visits at 24 and 36 months post-implantation
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
216 original 197 PAS
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Actual Number of Sites Enrolled |
31 sites
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Patient Follow-up Rate |
24mo – 176/197 = 89% 36mo – 161/197 = 82%
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Final Safety Findings |
Freedom from clinically driven TLR at 24 and 36 months were 77.43% and 73.43%, respectively. The lower confidence limit at 24 months was 70.9%, which is greater than the pre-specified performance goal of 60%. The lower bound of the confidence limit at 36 months was 66.4%, which is greater than the pre-specified performance goal of 55%.
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Final Effect Findings |
The mean Rutherford Score improved from a baseline value of 3.6 to a value of 1.6 at 24 Month follow-up and a value of 1.4 at 36 Month follow-up. The mean ABI improved from a baseline value of 0.693 to a value of 0.897 at 24 Month follow-up and a value of 0.913 at 36 Month follow-up.
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Study Strengths & Weaknesses |
The main study strength was the wide margin by which the PGs were met. The most frequent study deviations were being out of window study visits (98), missed study lab/assessments (82), and aspirin discontinuation (64). None of the recorded deviations affect the safety and welfare of the subjects or the integrity of the study results.
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Recommendations for Labeling Changes |
No labeling changes recommended.
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