SuperB Trial: SUrgical Versus PERcutaneous Bypass (SuperB)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass; Procedure: Surgical femoro-popliteal bypass.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Centre Groningen
  • Friesland
    • Drachten, Friesland, Netherlands
      • Nij Smellinghe hospital
    • Sneek, Friesland, Netherlands
      • Antonius Hospital
  • Gelderland
    • Arnhem, Gelderland, Netherlands
      • Rijnstate Hospital
    • Doetinchem, Gelderland, Netherlands
      • Slingeland Hospital
  • Overijssel
    • Zwolle, Overijssel, Netherlands
      • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heparin-bonded endoluminal fempop bypass; Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass	Procedure: 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.	Procedure: Surgical femoro-popliteal bypass.; Surgical femoro-popliteal bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life	5 years
Primary (and -assisted) patency	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Target lesion revascularisation	5 years
Secondary patency	5 years
Complications	5 years
Clinical improvement	5 years
Re-intervention	5 years

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: MMJP Reijnen, MD, PhD, Rijnstate Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: October 11, 2010
• First Submitted That Met QC Criteria: October 11, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; RCT; surgical; bypass; multicentre; patency; superficial femoral artery; endoluminal; vascular patency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 721-070910