Clinical trial NCT01220245: SuperB Trial: SUrgical Versus PERcutaneous Bypass
Official title: Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: endoluminal
surgical
bypass
patency
quality of life
multicentre
RCT
superficial femoral artery
vascular patency
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary (and -assisted) patency
timeFrame: 5 years
measure: Quality of life
timeFrame: 5 years
Secondary outcomes:
measure: Secondary patency
timeFrame: 5 years
measure: Complications
timeFrame: 5 years
measure: Clinical improvement
timeFrame: 5 years
measure: Re-intervention
timeFrame: 5 years
measure: Target lesion revascularisation
timeFrame: 5 years
Other outcomes:
Locations:
city: Drachten
country: Netherlands
facility: Nij Smellinghe Hospital
state: Friesland
city: Sneek
country: Netherlands
facility: Antonius Hospital
state: Friesland
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Doetinchem
country: Netherlands
facility: Slingeland Hospital
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala klinieken
state: Overijssel
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: Rijnstate Hospital
name: MMJP Reijnen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lensvelt MM, Holewijn S, Fritschy WM, Wikkeling OR, van Walraven LA, Wallis de Vries BM, Zeebregts CJ, Reijnen MM. SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial. Trials. 2011 Jul 18;12:178. doi: 10.1186/1745-6215-12-178.