NCT03119233

The DETOUR 2 Clinical Trial

The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single-arm, multi-center, international clinical investigation 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.

Detailed description

The DETOUR2 study is a prospective, single-arm, multi-center, international, non-randomized, safety and effectiveness clinical investigation of the PQ Bypass system. The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), with reference vessel diameters ranging from 5.0 - 6.7 mm, by investigator visual assessment.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	DETOUR System	The DETOUR System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm (TASC D) 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 (complex TASC C).

Timeline

• Start date: 2017-12-13
• Primary completion: 2021-12-22
• Completion: 2023-11-13
• First posted: 2017-04-18
• Last updated: 2025-04-02
• Results posted: 2025-04-02

Locations

34 sites across 3 countries: United States, Germany, Latvia

Regulatory

• FDA-regulated device study