Clinical trial NCT01174784: Chronic Total Occlusion Crossing With the Wildcat Catheter
Official title: A Non-randomized Study of the Avinger Wildcat Used to Cross Femoropopliteal CTOs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Chronic Total Occlusions
Superficial Femoral Artery
Popliteal Artery
Lead sponsor: Avinger, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Major Adverse Events
timeFrame: Index through 30-Day Follow-Up
measure: CTO Crossing Success Using the Wildcat
timeFrame: Index through 30-Day Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Heart Clinic
state: Alabama
city: Mesa
country: United States
facility: Arizona Regional / Adventis
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Heart Center
state: Arizona
city: Sacramento
country: United States
facility: Sutter Memorial
state: California
city: San Diego
country: United States
facility: Sharp Memorial
state: California
city: Pensacola
country: United States
facility: Coastal Vascular
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Mount Pleasant
country: United States
facility: Central Michigan Community Hospital
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Toledo
country: United States
facility: Jobst Vascular Center
state: Ohio
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: El Paso
country: United States
facility: Cardiology Care Consultants
state: Texas
city: El Paso
country: United States
facility: El Paso Cardiology Associates
state: Texas
Study officials:
affiliation: St. John Hospital
name: Tom Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: El Paso Cardiology Associates
name: Laiq Raja, MD
role: PRINCIPAL_INVESTIGATOR
References: