TORUS I Clinical Study

Status Active, not recruiting

Clinical Trial Summary

The primary objective of the feasibility study is to evaluate the safety and effectiveness of the PQ Bypass Stent Graft System in the treatment of atherosclerotic lesions of the native superficial femoral artery (SFA) or the superficial femoral and proximal popliteal arteries.

Clinical Trial Description

The primary safety endpoint for this study is freedom from a major adverse event (MAE) at 30 days post-procedure. An MAE is defined as TLR, amputation of the treated limb or death. The primary effectiveness endpoint is defined as stent patency as evidenced by a peak systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12-month visit window with no clinically-driven re-intervention within the stented segment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03128424
Study type	Interventional
Source	PQ Bypass, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 2016
Completion date	July 2021

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