NCT01775410

OptiCal COherence ToMography ABoard InformiNg AtherEctomy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Avinger, Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system. The trial is predominantly descriptive and, as such, not powered statistically although endpoint comparisons may be made to the published literature on peripheral atherectomy. 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 ≥ 3.0 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention. Trial success is focused on short term safety including rates of major adverse events. An evaluation of efficacy will also be performed and will include an evaluation of technical success 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.

Conditions

• Atherectomy in Diseased Lower Extremity Arteries

Interventions

Type	Name	Description
DEVICE	Wolverine System to perform atherectomy

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-27
• First posted: 2013-01-25
• Last updated: 2021-04-21
• Results posted: 2021-04-21

Locations

2 sites across 1 country: Colombia