Chronic Total Occlusion Crossing With the Wildcat Catheter

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT01174784

Run by

Avinger, Inc.

People needed

88

Starts

2010-08-01

Expected to finish

2011-06-01

Last updated by the study team

2020-07-17

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Birmingham Heart Clinic — Birmingham, Alabama, United States
• Arizona Regional / Adventis — Mesa, Arizona, United States
• Phoenix Heart Center — Phoenix, Arizona, United States
• 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
• St. Louis University — St Louis, Missouri, United States
• Jobst Vascular Center — Toledo, Ohio, United States
• Austin Heart — Austin, Texas, United States
• Cardiology Care Consultants — El Paso, Texas, United States
• El Paso Cardiology Associates — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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