NCT04130737

TORUS 2 IDE Clinical Study

The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	TORUS Stent Graft System	The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.

Timeline

• Start date: 2019-10-31
• Primary completion: 2023-01-06
• Completion: 2024-12-24
• First posted: 2019-10-17
• Last updated: 2024-03-07

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated device study