SuperB Trial: SUrgical Versus PERcutaneous Bypass

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Rijnstate Hospital
Sponsor:
Information provided by (Responsible Party):
Michel Reijnen, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01220245
First received: October 11, 2010
Last updated: August 5, 2013
Last verified: August 2013

October 11, 2010
August 5, 2013
October 2010
December 2019   (final data collection date for primary outcome measure)
  • primary (and -assisted) patency [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01220245 on ClinicalTrials.gov Archive Site
  • secondary patency [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • clinical improvement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • re-intervention [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • target lesion revascularisation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
  • 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: heparin-bonded ePTFE endoluminal fem-pop 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
222
December 2019
December 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age over 18 years
  • informed consent
  • de 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
Both
18 Years and older
No
Contact: MMPJ Reijnen, MD, PhD 0031260058888 ext 3154 mreijnen@alysis.nl
Contact: MMA Lensvelt, MD 0031641266258 superbtrial@gmail.com
Netherlands
 
NCT01220245
721-070910
No
Michel Reijnen, Rijnstate Hospital
Rijnstate Hospital
Not Provided
Principal Investigator: MMJP Reijnen, MD, PhD Rijnstate Hospital
Study Chair: MMA Lensvelt, MD Rijnstate Hospital
Rijnstate Hospital
August 2013

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