NCT03128424

TORUS I Clinical Study

Long Segment Lesion Peripheral Artery Revascularization Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	PQ Bypass Stent Graft System	The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-07-01
• Completion: 2021-09-01
• First posted: 2017-04-25
• Last updated: 2025-10-29
• Results posted: 2025-10-29

Regulatory

• FDA-regulated device study