OptiCal COherence ToMography ABoard InformiNg AtherEctomy (COMBINE)
This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention.
Atherectomy in Diseased Lower Extremity Arteries.
Device: Wolverine System to perform atherectomy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Non-randomized, Multi-center Feasibility Trial of the Avinger Wolverine System, an Atherectomy Device That Provides Directional Visualization and Imaging While Removing Plaque in Diseased Lower Extremity Arteries|
- Safety [ Time Frame: Through 30 day follow-up ] [ Designated as safety issue: Yes ]
Freedom from major adverse events (MAE) through 30 day follow-up:
- Clinically driven target lesion revascularization (TLR)
- Myocardial infarct (MI)
- Cardiovascular related deaths
- Unplanned, major index limb amputation
Device Related Events:
- Clinically Significant Perforations
- Clinically Significant Dissections
- Clinically Significant Embolus
- Effectiveness [ Time Frame: During interventional procedure ] [ Designated as safety issue: No ]Technical success is defined as the percent of target lesions that has a residual diameter stenosis < 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate
- Secondary Safety Endpoint [ Time Frame: During interventional procedure ] [ Designated as safety issue: Yes ]Freedom from procedural emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator
- Secondary Effectiveness Endpoints [ Time Frame: At 30 days ] [ Designated as safety issue: No ]• Procedural success defined as the percent of target lesions that have residual diameter stenosis ≤30% post-Wolverine and any other adjunctive therapy.
- Secondary Effectiveness Endpoints [ Time Frame: At 30 days ] [ Designated as safety issue: No ]Ankle-Brachial Index at 30 days
- Secondary Effectiveness Endpoints [ Time Frame: At 30 days ] [ Designated as safety issue: No ]Rutherford Classification at 30 days.
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|Device: Wolverine System to perform atherectomy|