At a glance
ClinicalIndex Comparison Record- ✓Age >18 and ≤90 years
- ✓Chronic symptomatic lower limb ischemia (Rutherford clinical categories 3, 4, or 5)
- ✓Symptomatic femoropopliteal chronic total occlusions ≥20 cm (TASC D) or complex TASC C lesions ≥24 cm total length
- ✓Reference vessel diameter 4.5–6.7 mm
- ✕Rutherford clinical category 0, 1, 2, or 6
- ✕Prior distal amputation (above the transmetatarsal) of target limb
- ✕Planned major amputation or minor amputation above ankle of target limb
- ✕History of deep vein thrombosis on either limb
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial
In Brief
A clinical study evaluating DETOUR System for Peripheral Arterial Disease. Completed, enrolled 202 participants across 34 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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).