A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery (OSPREY)
OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the inclusion and none of the exclusion criteria are met. The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days, 6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY study after he/she signs the informed consent and meets all inclusion/exclusion criteria.
The study objectives are to demonstrate that efficacy and safety of this novel stent design are not inferior to historical Percutaneous Transluminal Angioplasty (PTA) and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical trial of the Misago™ Self-Expanding Stent System for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.
|Peripheral Vascular Disease||Device: Misago™ Self-Expanding Stent System||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery|
- Primary Effectiveness Endpoint [ Time Frame: 12 Months post-procedure ]The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.
- Primary Safety Endpoint [ Time Frame: 30 days post-procedure ]The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.
- Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort [ Time Frame: 12 Months post-procedure ]Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).
- Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort [ Time Frame: 12 Months post-procedure ]The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)
- Occurrence of Target Lesion Revascularization [ Time Frame: 12 Months post-procedure ]
The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure.
Clinically driven defined as:
- More than 50 percent stenosis with worsening symptoms, OR
- More than 70 percent stenosis without symptoms
- Device Related Peri-Procedural Complications [ Time Frame: Prior to Hosptial Discharge ]Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)
- Technical Success [ Time Frame: Intra-procedure ]
Technical Success defined by the following conditions:
- Successful delivery of the stent at the lesion site
- Stent(s) successfully deployed in lesion with adequate lesion coverage
- Procedural Success [ Time Frame: Intra-procedure ]Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel
- Clinical Success [ Time Frame: 30 days post-procedure ]Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline
- Major Adverse Events (MAEs) Through 12 Months Post-procedure [ Time Frame: 12 Months post-procedure ]The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.
- Stent Fracture at 12 Months [ Time Frame: 12 Months post-procedure ]Occurrence of stent fracture as determined by core laboratory analysis
|Study Start Date:||July 2010|
|Study Completion Date:||April 2016|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Misago™ Self-Expanding Stent System||
Device: Misago™ Self-Expanding Stent System
Transcatheter placement of an intravascular stent(s)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118117
Show 31 Study Locations
|Principal Investigator:||John F Angle, MD||University of Virginia|