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Clinical Trial Summary

To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.


Clinical Trial Description

Single Arm, prospective, OUS multi-center feasibility study enrolling up to 30 subjects with superficial femoral or popliteal lesions. The study will capture acute angiographic data to compare the pre- Serranator™ inflation vs post inflation effects.

The study population will consist of subjects with claudication or ischemic rest pain, with de novo or non-stented restenotic lesions in femoropopliteal arteries having lesion length less than or equal to 10 cm, total occlusion up to 6 cms in length and reference vessel diameter of 4 mm to 6 mm, inclusive. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03001700
Study type Interventional
Source Cagent Vascular LLC
Contact
Status Completed
Phase N/A
Start date February 1, 2017
Completion date December 31, 2017

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