Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatments heparin-bonded eptfe endoluminal fem-pop bypass, surgical femoro-popliteal bypass.
Sponsor Rijnstate Hospital
Start date October 2010
End date July 2020
Trial size 126 participants
Trial identifier NCT01220245, 721-070910

Summary

In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass
heparin-bonded eptfe endoluminal fem-pop bypass
Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass
(Active Comparator)
Surgical femoro-popliteal bypass.
surgical femoro-popliteal bypass.
Surgical femoro-popliteal bypass.

Primary Outcomes

Measure
Primary (and -assisted) patency
time frame: 5 years
Quality of life
time frame: 5 years

Secondary Outcomes

Measure
Secondary patency
time frame: 5 years
Complications
time frame: 5 years
Clinical improvement
time frame: 5 years
Re-intervention
time frame: 5 years
Target lesion revascularisation
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age over 18 years - Informed consent - Novo stenosis, restenosis >50% or occlusion of the native SFA, all > 10cm in length - Patent popliteal artery at the upper margin of the patella to the trifurcation - Diameter native SFA and popliteal artery are 5.0-7.5 mm - Indication for surgical bypass - Distal run-off at least one crural artery without significant stenosis - Ankle-brachial index (ABI) at rest < 0.8 in the study limb prior to procedure Exclusion Criteria: - Patient unsuitable for administration of contrast agent - Pregnancy - Dementia or altered mental status that would prohibit giving conscious informed consent - Need for adjunctive major surgical or vascular procedures within one month - Untreated flow-limiting aortoiliac occlusive disease - Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment - Femoral or popliteal aneurysm of target vessel - Non-arthrotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis) - Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol - Major distal amputation (above the transmetatarsal) in the study limb - Any previously known coagulation disorder, including hypercoagulability - Contraindication to anticoagulation or antiplatelet therapy - Known allergies to stent/stent-graft components - History of prior life-threatening reaction to contrast agent - Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II - Planned surgical procedure or major amputation to occur after enrollment of the patient

Additional Information

Official title Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial
Principal investigator MMJP Reijnen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Rijnstate Hospital.