Chronic Total Occlusion Crossing With the Wildcat Catheter (CONNECT)

Avinger

Status: Completed

Conditions: Peripheral Arterial Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01174784

AVI CTO 10001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Treatment

Experimental group

Description:

The Wildcat catheter is a CTO crossing catheter. Subjects will be subjected to crossing with this device.

Treatment:

Device: Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer