The DETOUR II Clinical Study
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|ClinicalTrials.gov Identifier: NCT03119233|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: PQ Bypass System||Not Applicable|
The DETOUR II 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 >15 cm long occlusions and diffuse stenoses of femoropopliteal arteries, including in-stent re-stenosis, with reference vessel diameters ranging from 5.0 - 6.7 mm.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||212 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PQ Bypass System for Femoropopliteal Bypass II|
|Actual Study Start Date :||December 13, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||June 2023|
The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.
Device: PQ Bypass System
The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to >15 cm long occlusions and diffuse stenoses of femoro-popliteal arteries, including in-stent re-stenosis, with reference vessel diameters ranging from 5.0 - 6.7 mm
- Primary Effectiveness Endpoint [ Time Frame: 12 months ]The rate of primary patency at 12 months defined as: no evidence of clinically significant stenosis (>/= 50%) based on duplex ultrasound (peak systolic velocity ratio of >2.5) within the stent graft or immediately above or below the treated arterial segment, and no clinically-driven re-intervention within the stented segment.
- Primary Safety Endpoint [ Time Frame: 30 days ]Freedom from a major adverse event (MAE) at 30 days post-procedure. MAE includes: Death; Target lesion revascularization (TLR) defined as any repeat percutaneous intervention of the target lesions (including 5 mm proximal and distal to the index device) or surgical bypass of the target vessel performed for the restenosis or other complication involving the target lesion; amputation of the treated limb; symptomatic deep vein thrombosis (DVT); pulmonary embolism (PE); and, procedure related bleeding requiring any transfusion of packed red blood cells or surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119233
|Contact: Victoria Versprille||+1 (908) email@example.com|
|Principal Investigator:||Jihad Mustapha, MD||Advanced Cardiac and Vascular Amputation Prevention Centers|
|Principal Investigator:||Sean Lyden, MD||The Cleveland Clinic|