NCT01174784

Chronic Total Occlusion Crossing With the Wildcat Catheter

A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Avinger, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up.

Detailed description

Patients with a CTO, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. Following providing informed consent, the CTO will be addressed by the Wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the CTO. Data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer	A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2010-08-04
• Last updated: 2020-07-17
• Results posted: 2013-09-27

Locations

15 sites across 1 country: United States