Chronic Total Occlusion Crossing With the Wildcat Catheter

Not Applicable

Completed

Interventions: Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Patient is willing and able to provide informed consent.
Patient is willing and able to comply with the study protocol.
Patient is > 18 years old.
Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate.
Target femoropopliteal vessel is ≥ 3.0 mm in diameter.
Patient has Rutherford Classification of 2-5.

Exclusion Criteria

Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
Patient has a known sensitivity or allergy to anti-platelet medications.
Patient is pregnant or lactating.
Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
Target vessel is severely calcified as evidenced by angiography.
Target lesion is in a bypass graft.
Target lesion is in a stent (i.e., in-stent restenosis).
Patient has had a procedure on the target limb within 7 days.
Patient has had a procedure on the target limb within the past 30 days and is unstable.
Patient is simultaneously participating in an investigational device or drug study.
Patient has a planned surgical or interventional procedure within 30 days after the study procedure.

Arm && Interventions

Group	Intervention	Description
Treatment	Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer	The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device.

Primary Outcome Measures

Name	Time	Method
CTO Crossing Success Using the Wildcat	Index through 30-Day Follow-Up	Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.
Major Adverse Events	Index through 30-Day Follow-Up	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.

Secondary Outcome Measures

Name	Time	Method

Locations (15): Coastal Vascular
🇺🇸
Pensacola, Florida, United States
Cardiology Care Consultants
🇺🇸
El Paso, Texas, United States
St. Louis University
🇺🇸
Saint Louis, Missouri, United States
Sutter Memorial
🇺🇸
Sacramento, California, United States
Birmingham Heart Clinic
🇺🇸
Birmingham, Alabama, United States
Sharp Memorial
🇺🇸
San Diego, California, 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
Phoenix Heart Center
🇺🇸
Phoenix, Arizona, United States
Arizona Regional / Adventis
🇺🇸
Mesa, Arizona, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Jobst Vascular Center
🇺🇸
Toledo, Ohio, United States
El Paso Cardiology Associates
🇺🇸
El Paso, Texas, United States
Austin Heart
🇺🇸
Austin, Texas, United States