SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial

Trials

Michel MPJ Reijnen⁵  Clark J Zeebregts²  Bas M Wallis de Vries²  Laurens A van Walraven³  Otmar RM Wikkeling⁴  Wilbert M Fritschy¹  Suzanne Holewijn⁵  Mare MA Lensvelt⁵ 

[1] Isala Klinieken, Department of Surgery, Zwolle, The Netherlands;University Medical Center Groningen, Department of Surgery, Division of Vascular Surgery, Groningen, The Netherlands;Antonius Hospital, Department of Surgery, Sneek, The Netherlands;Nij Smellinghe Hospital, Department of Surgery, Drachten, The Netherlands;Rijnstate Hospital, Department of Surgery, Arnhem, The Netherlands

关键词: peripheral arterial occlusive disease;    stentgraft;    endoluminal;    femoro-popliteal bypass;    superficial femoral artery;   

Others  :  1095922
DOI  :  10.1186/1745-6215-12-178

 received in 2011-05-14, accepted in 2011-07-18,  发布年份 2011

【 摘 要 】

Background

Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not.

Methods/design

Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications.

Discussion

The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications.

Trial Registration

Clinicaltrials: NCT01220245

【 授权许可】

   
2011 Lensvelt et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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