NCT03693963

The PRELUDE BTK Study

PRospective Study for the TrEatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Using the Serranator® DevicE: PRELUDE BTK (Below The Knee) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Cagent Vascular LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.

Detailed description

Single arm, prospective, multi-center feasibility study enrolling up to 48 subjects with atherosclerotic lesions in the infrapopliteal arteries and/or Critical Limb Ischemia (CLI). The study will capture acute angiographic data to compare the pre-Serranator® inflation vs post inflation effects and will include 6 month clinical follow up. The study population will consist of subjects with claudication or CLI, with de novo stenoses or non-stented restenotic or total occlusion lesions in infrapopliteal arteries having lesion length up to and including 12 cm in length and reference vessel diameter of 2.5 mm to 3.5 mm inclusive.

Conditions

• Peripheral Arterial Disease
• Critical Limb Ischemia

Interventions

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

Timeline

• Start date: 2019-12-17
• Primary completion: 2020-04-11
• Completion: 2020-10-23
• First posted: 2018-10-03
• Last updated: 2021-01-28

Locations

6 sites across 4 countries: Austria, Germany, New Zealand, Poland

Regulatory

• FDA-regulated device study