The DETOUR2 Clinical Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: PQ Bypass System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study: General Inclusion Criteria Age > 18 and ≤ 90 years of age. Willing and able to provide informed consent. Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months. Clinical Inclusion Criteria Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5. Venous Clinical Severity Score < 3. Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair. Angiographic Inclusion Criteria 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), by investigator visual assessment. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment. Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone Able to successfully access the SFA origin for entry of the crossing device. At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle or foot. A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention. General Exclusion Criteria Participating in another investigational clinical study. Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. Clinical Exclusion Criteria History of deep vein thrombosis on either limb. Thrombophlebitis, within the previous 30 days. 6. Planned major amputation of the target limb, including minor amputation (above the ankle). Prior distal amputation (above the transmetatarsal) of the target limb. Known or suspected active infection at the time of the procedure (e.g., WIfI foot infection grade 3: Severe infection. Local infection with systemic inflammatory response syndrome [SIRS]) Rutherford clinical category 0, 1, 2 or 6. Has acute or chronic renal disease with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis. Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed. Morbid obesity that does not allow for safe vascular access or imaging. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR > 1.8. Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion. Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months. Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria Stent within 3 cm of SFA ostium. Previous bypass surgery on the target limb. Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication) Presence of aneurysm or acute thrombus in the target limb. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-Arm<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | 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. | 12 months | 
| Primary Safety Endpoint | 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. | 30 days |