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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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| 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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