Peripheral Arterial Disease Clinical Trial
Official title:
Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Heart Center Leipzig/Park Hospital | Leipzig | |
Germany | Klinikum Rosenheim | Rosenheim | |
Germany | Universitat Klinik Tubingen | Tubingen | |
Russian Federation | Endosurgery and Lithotripsy Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
Cook |
Germany, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Late Lumen Loss | 6 months | No |
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