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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
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Procedure: heparin-bonded ePTFE endoluminal fem-pop bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 222
Study Start Date: October 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: heparin-bonded ePTFE endoluminal fem-pop bypass
heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220245

Contacts
Contact: MMPJ Reijnen, MD, PhD 0031260058888 ext 3154 mreijnen@alysis.nl
Contact: MMA Lensvelt, MD 0031641266258 superbtrial@gmail.com

Locations
Netherlands
Nij Smellinghe Hospital Recruiting
Drachten, Friesland, Netherlands
Contact: ORM Wikkeling, MD         
Antonius Hospital Recruiting
Sneek, Friesland, Netherlands
Contact: L.A. Walraven, MD         
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands
Contact: MMPJ Reijnen, MD, PhD    0031260058888 ext 3154    mreijnen@alysis.nl   
Contact: MMA Lensvelt, MD    0031641266258    m.m.a.lensvelt@gmail.com   
Slingeland Hospital Recruiting
Doetinchem, Gelderland, Netherlands
Contact: S Lemson, MD         
Isala klinieken Recruiting
Zwolle, Overijssel, Netherlands
Contact: WM Fritschy, MD, PhD         
University Medical Centre Groningen Recruiting
Groningen, Netherlands
Contact: BM Wallis de Vries, MD, PhD       b.m.wallisdevries@chir.umcg.nl   
St Jansdal Hospital Recruiting
Harderwijk, Netherlands
Contact: Rene The, MD         
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: MMJP Reijnen, MD, PhD Rijnstate Hospital
Study Chair: MMA Lensvelt, MD Rijnstate Hospital
  More Information

No publications provided by Rijnstate Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Reijnen, Principal Investigator, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01220245     History of Changes
Other Study ID Numbers: 721-070910
Study First Received: October 11, 2010
Last Updated: August 5, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
endoluminal
surgical
bypass
patency
quality of life
multicentre
RCT
superficial femoral artery
vascular patency

Additional relevant MeSH terms:
Cardiovascular Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014