NCT06315023

The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)

Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Endologix · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.

Detailed description

A maximum of 450 subjects will be enrolled with a target study population of at least 200 evaluable female and 200 evaluable male participants at the 12-month post-procedure follow-up visit. A maximum of 200 US sites. Sites will be selected that participate or will participate in the VQI PVI Registry. Follow up visits/assessments will be completed at 1, 12, 24-, 36-, 48-, and 60-months post-procedure. Study enrollment is expected to conclude over 4 years. Follow up data at 1 year is expected to conclude in 5 years from enrollment, with 5-year follow up expected to conclude in 9 years from enrollment.

Conditions

• Peripheral Arterial Disease
• Symptomatic Femoropopliteal Lesions

Interventions

Type	Name	Description
DEVICE	DETOUR System	Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System

Timeline

• Start date: 2023-10-06
• Primary completion: 2028-06-07
• Completion: 2032-06-07
• First posted: 2024-03-18
• Last updated: 2025-05-11

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study