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Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis — SHIELD  

Peripheral Arterial Disease Clinical Trial

Official title:
A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery

Clinical Trial Summary

The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.

Clinical Trial Description

This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02568293
Study type Interventional
Source Symic Vascular
Contact
Status Active, not recruiting
Phase N/A
Start date October 2015
Completion date October 2017
View Details
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