SuperB Trial: SUrgical Versus PERcutaneous Bypass

NCT01220245 | Completed

• 1 other identifier: 721-070910
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 6

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.

Conditions

Cardiovascular Diseases

Keywords

endoluminal; surgical; bypass; patency; quality of life; multicentre; RCT; superficial femoral artery; vascular patency

Outcome Measures

Primary Outcomes (2)

• Primary (and -assisted) patency

  5 years

• Quality of life

  5 years

Secondary Outcomes (5)

• Secondary patency

  5 years

• Complications

  5 years

• Clinical improvement

  5 years

• Re-intervention

  5 years

• Target lesion revascularisation

  5 years

Study Arms (2)

Heparin-bonded endoluminal fempop bypass

EXPERIMENTAL

Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass

Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass

Surgical femoro-popliteal bypass

ACTIVE COMPARATOR

Surgical femoro-popliteal bypass.

Procedure: Surgical femoro-popliteal bypass.

Interventions

Heparin-bonded ePTFE endoluminal fem-pop bypass PROCEDURE

Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass

Heparin-bonded endoluminal fempop bypass

Surgical femoro-popliteal bypass. PROCEDURE

Surgical femoro-popliteal bypass.

Surgical femoro-popliteal bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (6)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

Slingeland Hospital

Doetinchem, Gelderland, Netherlands

Location

Isala klinieken

Zwolle, Overijssel, Netherlands

Location

Nij Smellinghe Hospital

Drachten, Provincie Friesland, Netherlands

Location

Antonius Hospital

Sneek, Provincie Friesland, Netherlands

Location

University Medical Centre Groningen

Groningen, Netherlands

Location

Related Publications (2)

• van Walraven LA, Velandia-Sanchez A, Iqbal K, Zeebregts CJ, Holewijn S, Reijnen MMPJ. Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass. J Endovasc Ther. 2026 Feb;33(1):220-226. doi: 10.1177/15266028241245602. Epub 2024 Apr 9.

  PMID: 38590283 DERIVED

• 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.

  PMID: 21767371 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• MMJP Reijnen, MD, PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

NL (6)