Advance® 18PTX® Balloon Catheter Study

Cook Group

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: Advance® 18PTX® Balloon Catheter

Device: Advance® 18LP Balloon Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00776906

190007, PCBS

08-008

Details and patient eligibility

About

The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Age >18 years.
Able to provide informed consent.
Has at least one de novo or restenotic lesion(s) with > 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion.

Key Exclusion Criteria:

Has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure.
Lack of at least one patent runoff vessel with < 50% stenosis throughout its course.
Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.