SuperB Trial: SUrgical Versus PERcutaneous Bypass

Cardiovascular Diseases Clinical Trial

— SuperB  

Official title:

Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220245
• Other study ID #: 721-070910
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: August 2020

Study information

• Verified date: January 2021
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Procedure:
• Heparin-bonded ePTFE endoluminal fem-pop bypass
Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass
• Surgical femoro-popliteal bypass.
Surgical femoro-popliteal bypass.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Slingeland Hospital	Doetinchem	Gelderland
Netherlands	Nij Smellinghe Hospital	Drachten	Friesland
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	Antonius Hospital	Sneek	Friesland
Netherlands	Isala klinieken	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary (and -assisted) patency		5 years
Primary	Quality of life		5 years
Secondary	Secondary patency		5 years
Secondary	Complications		5 years
Secondary	Clinical improvement		5 years
Secondary	Re-intervention		5 years
Secondary	Target lesion revascularisation		5 years