NCT02471638

DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass

PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Detailed description

Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	PQ Bypass System for Femoropopliteal Bypass	To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-09-01
• Completion: 2020-06-01
• First posted: 2015-06-15
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

8 sites across 6 countries: Chile, Germany, Italy, Latvia, New Zealand, Poland

Regulatory

• FDA-regulated device study