The DETOUR2 Clinical Study
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|ClinicalTrials.gov Identifier: NCT03119233|
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: PQ Bypass System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||202 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial|
|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
Intended use from CLN114 Rev F (CLN114 is the DETOUR2 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 (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).
- Primary Effectiveness Endpoint [ Time Frame: 12 months ]The absence of clinically-driven target lesion revascularization and/or absence of recurrent target lesion diameter stenosis >50% by imaging (e.g., duplex ultrasound (peak systolic velocity ratio of >2.5) or invasive angiography) with the stent or immediately 1 cm above or below the treated segment.). When both modalities are available, angiography takes precedence.
- Primary Safety Endpoint [ Time Frame: 30 days ]Freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or 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
|Principal Investigator:||Jihad Mustapha, MD||Advanced Cardiac and Vascular Amputation Prevention Centers|
|Principal Investigator:||Sean Lyden, MD||The Cleveland Clinic|