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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
Birmingham Heart Clinic
Birmingham, Alabama, United States
Arizona Regional / Adventis
Mesa, Arizona, United States
Phoenix Heart Center
Phoenix, Arizona, United States
Major Adverse Events
The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.
Time frame: Index through 30-Day Follow-Up
CTO Crossing Success Using the Wildcat
Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.
Time frame: Index through 30-Day Follow-Up
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Sutter Memorial
Sacramento, California, United States
Sharp Memorial
San Diego, California, United States
Coastal Vascular
Pensacola, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Detroit Medical Center
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Central Michigan Community Hospital
Mount Pleasant, Michigan, United States
...and 5 more locations