The PRELUDE BTK Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03693963
Study type	Interventional
Source	Cagent Vascular LLC
Contact
Status	Completed
Phase	N/A
Start date	December 17, 2019
Completion date	October 23, 2020

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