Serranator Recoil Study

Status Recruiting

Clinical Trial Summary

The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.

Clinical Trial Description

Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05161039
Study type	Interventional
Source	Cagent Vascular LLC
Contact	Robert Giasolli
Phone	610.688.2006
Email	rgiasolli@cagentvascular.com
Status	Recruiting
Phase	N/A
Start date	November 15, 2021
Completion date	July 2022

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