Peripheral Arterial Disease
Conditions
Brief summary
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.
Interventions
DEVICEAdvance® 18PTX® Balloon Catheter
DEVICEAdvance® 18LP Balloon Catheter
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Late Lumen Loss | 6 months |
Countries
Germany, Russia
Outcome results
None listed