NCT04625660

Detour2 Continued Access Study

The DETOUR2 Continued Access Clinical Trial - The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - Continued Access Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single-arm, multi-center, clinical investigation to continue to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Conditions

• Peripheral Artery Diseases

Interventions

Type	Name	Description
DEVICE	PQ Bypass System	Intended use from CLN232 Rev A (CLN232 is the DETOUR2 Continued Access Protocol) The PQ Bypass System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis.

Timeline

• Start date: 2021-04-07
• Primary completion: 2024-05-14
• Completion: 2024-05-14
• First posted: 2020-11-12
• Last updated: 2024-10-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study