Status:
COMPLETED
Advance® 18PTX® Balloon Catheter Study
Lead Sponsor:
Cook Group Incorporated
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ar...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00776906
Start Date
October 1 2008
End Date
December 1 2013
Last Update
January 21 2015
Active Locations (4)
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1
Heart Center Leipzig/Park Hospital
Leipzig, Germany, 04289
2
Klinikum Rosenheim
Rosenheim, Germany, 83022
3
Universitat Klinik Tubingen
Tübingen, Germany, 72076
4
Endosurgery and Lithotripsy Center
Moscow, Russia, 111123