DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: PQ Bypass System for Femoropopliteal Bypass
- Registration Number
- NCT02471638
- Lead Sponsor
- Endologix
- Brief Summary
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
- Detailed Description
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
-
Willing and able to provide informed consent
-
Age 18 or older
-
Rutherford Classification of 3-5
-
Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath
-
Femoro-popliteal lesions ≥10 cm in length considered to be:
- Chronic total occlusion (100% stenosis)
- Diffuse stenosis (>50% stenosis) with moderate to heavy calcification
- In-stent restenosis (>50% stenosis)
-
Proximal and distal target vessels are 5.4-7.0 mm in diameter
-
Orifice and proximal 1 cm of SFA is patent
-
Patent popliteal artery 3 cm proximal to tibial plateau
-
At least 1 patent tibial artery to the foot
-
Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein
-
Subject has > one year life expectancy
- Bypass length required > 30 cm
- History of deep vein thrombosis
- Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment;
- Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months
- Pregnant or nursing
- Untreated flow-limiting aortoiliac occlusive disease
- Has renal failure (eGFR < 30mL/min)
- Major distal amputation (above the transmetatarsal) in the study or non-study limb
- Patient has had a revascularization procedure on the target limb within 30 days
- Patient has a planned amputation of the target limb
- Previous bypass surgery on the target limb
- Patient is participating in another clinical study for which follow-up is currently on going.
- Patient has a condition that in the view of the investigator precludes participation in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm study PQ Bypass System for Femoropopliteal Bypass PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass
- Primary Outcome Measures
Name Time Method Number of Lesions With Primary Patency 6 Months Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure One Month composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure
- Secondary Outcome Measures
Name Time Method Number of Major Adverse Events at the 12-Month Time Point 12 Months Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure One Month Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure
Percentage of Lesions With Primary Patency at 12 Months Post-Procedure 12 Months Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).
Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb One Month Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point.
Major Adverse Vascular Event (MAVE) Rate One Month Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion \>2 units, and symptomatic deep vein thrombosis on ipsilateral limb
Number of Major Adverse Events at the 3 Year Time Point 3 Years Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Major Adverse Vascular Event (MAVE) Rate at 3 Years 3 Years Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion \>2 units, and symptomatic deep vein thrombosis on ipsilateral limb.
Trial Locations
- Locations (8)
Vascular Service
🇳🇿Auckland, New Zealand
Ospedale San Raffaele
🇮🇹Milan, Italy
Universidad Católica de Chile
🇨🇱Santiago, Chile
University of Leipzig Medical Centre
🇩🇪Leipzig, Germany
Stradins University Hospital
🇱🇻Riga, Latvia
Institute of Haematology Medicine Indira Gandhi
🇵🇱Warsaw, Poland
Gdansk Medical University
🇵🇱Gdańsk, Poland
Poznan University of Medical Sciences
🇵🇱Poznan, Poland