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SuperB Trial: SUrgical Versus PERcutaneous Bypass (SuperB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01220245
Recruitment Status : Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Michel Reijnen, Rijnstate Hospital

October 11, 2010
October 13, 2010
April 11, 2017
October 2010
July 2020   (Final data collection date for primary outcome measure)
  • Primary (and -assisted) patency [ Time Frame: 5 years ]
  • Quality of life [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01220245 on Archive Site
  • 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 ]
Same as current
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SuperB Trial: SUrgical Versus PERcutaneous Bypass
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cardiovascular Diseases
  • Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass
    Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass
  • Procedure: Surgical femoro-popliteal bypass.
    Surgical femoro-popliteal bypass.
  • Experimental: Heparin-bonded endoluminal fempop bypass
    Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass
    Intervention: Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass
  • Active Comparator: Surgical femoro-popliteal bypass
    Surgical femoro-popliteal bypass.
    Intervention: Procedure: Surgical femoro-popliteal bypass.
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
July 2020
July 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Michel Reijnen, Rijnstate Hospital
Rijnstate Hospital
Not Provided
Principal Investigator: MMJP Reijnen, MD, PhD Rijnstate Hospital
Rijnstate Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP