DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm study

PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass

Group Type EXPERIMENTAL

PQ Bypass System for Femoropopliteal Bypass

Intervention Type DEVICE

To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Interventions

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PQ Bypass System for Femoropopliteal Bypass

To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No