DETOUR I Clinical Study

Peripheral Arterial Disease Clinical Trial

Official title:

PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02471638
• Other study ID #: STP 115
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2020

Study information

• Verified date: June 2019
• Source: PQ Bypass, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: September 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• PQ Bypass System for Femoropopliteal Bypass
To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Locations

Country	Name	City	State
Chile	Universidad Católica de Chile	Santiago
Germany	University of Leipzig Medical Centre	Leipzig
Italy	Ospedale San Raffaele	Milan
Latvia	Stradins University Hospital	Riga
New Zealand	Vascular Service	Auckland
Poland	Gdansk Medical University	Gdansk
Poland	Poznan University of Medical Sciences	Poznan
Poland	Institute of Haematology Medicine Indira Gandhi	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
PQ Bypass, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Performance Endpoint (Rate of primary patency)	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).	6 months