NCT03001700

PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE

PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE: PRELUDE Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Cagent Vascular LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Serranator™ Alto PTA Serration Balloon Catheter	The Serranator™ is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-05-31
• Completion: 2017-12-31
• First posted: 2016-12-23
• Last updated: 2018-04-24

Locations

4 sites across 3 countries: Austria, New Zealand, Poland

Regulatory

• FDA-regulated device study