Status:
COMPLETED
Chronic Total Occlusion Crossing With the Wildcat Catheter
Lead Sponsor:
Avinger, Inc.
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
19+ years
Phase:
NA
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 inde...
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 Wild...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01174784
Start Date
August 1 2010
End Date
June 1 2011
Last Update
July 17 2020
Active Locations (15)
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1
Birmingham Heart Clinic
Birmingham, Alabama, United States, 35235
2
Arizona Regional / Adventis
Mesa, Arizona, United States, 85206
3
Phoenix Heart Center
Phoenix, Arizona, United States, 85006
4
Sutter Memorial
Sacramento, California, United States, 95619