DETOUR I Clinical Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02471638
• Date of registration: 11/06/2015
• Prospective Registration: No
• Primary sponsor: PQ Bypass, Inc.
• Public title: DETOUR I Clinical Study
• Scientific title: PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
• Date of first enrolment: January 2015
• Target sample size: 78
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02471638
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Chile, Germany, Italy, Latvia, New Zealand, Poland

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Disease

Intervention(s)

Device: PQ Bypass System for Femoropopliteal Bypass

Primary Outcome(s)

Primary Performance Endpoint (Rate of primary patency) [Time Frame: 6 months]

Secondary ID(s)

STP 115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors