Peripheral Artery Diseases
Conditions
Brief summary
Prospective, single-arm, multi-center, clinical investigation to continue 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.
Interventions
DEVICEPQ Bypass System
Intended use from CLN232 Rev A (CLN232 is the DETOUR2 Continued Access 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 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.
Sponsors
Endologix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Age \> 18 and ≤ 90 years of age. 2. Willing and able to provide informed consent. 3. Subject is willing to undergo all follow-up assessments according to the specified schedule over 24 months. Clinical Inclusion Criteria 4. Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5. 5. Venous Clinical Severity Score \< 3. 6. Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair. Angiographic Inclusion Criteria 7. Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm 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, by investigator visual assessment. 8. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment. 9. Subject has a patent popliteal artery (\<50% stenosis) distal to the landing zone 10. Able to successfully access the SFA origin for entry of the crossing device. 11. At least one patent infrapopliteal vessel (\<50% stenosis) with run-off to the ankle or foot. 12. 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
1. Participating in another investigational clinical study that has not reached the study endpoint or interferes with endpoints of this study 2. 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. 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint at 30 Days | 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 the Treated Limb, Symptomatic Deep Vein Thrombosis (DVT), or Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery. |
| Primary Effectiveness Endpoint - Patency at 12 Months | 12 Months | The absence of clinically-driven target lesion revascularization and absence of recurrent target lesion diameter stenosis \>50% by imaging (e.g., duplex ultrasound peak systolic velocity ratio of \>2.5 or invasive angiography) within the stent or immediately 1 cm above or below the treated segment. When both modalities are available, angiography takes precedence. |
Countries
United States
Outcome results
None listed