SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial
<p>Abstract</p> <p>Background</p> <p>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 pr...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2011-07-01
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| Series: | Trials |
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| Online Access: | http://www.trialsjournal.com/content/12/1/178 |
| _version_ | 1811320147875463168 |
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| author | Wallis de Vries Bas M van Walraven Laurens A Wikkeling Otmar RM Fritschy Wilbert M Holewijn Suzanne Lensvelt Mare MA Zeebregts Clark J Reijnen Michel MPJ |
| author_facet | Wallis de Vries Bas M van Walraven Laurens A Wikkeling Otmar RM Fritschy Wilbert M Holewijn Suzanne Lensvelt Mare MA Zeebregts Clark J Reijnen Michel MPJ |
| author_sort | Wallis de Vries Bas M |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>Clinicaltrials: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01220245">NCT01220245</a></p> |
| first_indexed | 2024-04-13T12:54:13Z |
| format | Article |
| id | doaj.art-d13a70d475aa43fcb398fb45266df352 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T12:54:13Z |
| publishDate | 2011-07-01 |
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| spelling | doaj.art-d13a70d475aa43fcb398fb45266df3522022-12-22T02:46:06ZengBMCTrials1745-62152011-07-0112117810.1186/1745-6215-12-178SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trialWallis de Vries Bas Mvan Walraven Laurens AWikkeling Otmar RMFritschy Wilbert MHolewijn SuzanneLensvelt Mare MAZeebregts Clark JReijnen Michel MPJ<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>Clinicaltrials: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01220245">NCT01220245</a></p>http://www.trialsjournal.com/content/12/1/178superficial femoral arteryfemoro-popliteal bypassendoluminalstentgraftperipheral arterial occlusive disease |
| spellingShingle | Wallis de Vries Bas M van Walraven Laurens A Wikkeling Otmar RM Fritschy Wilbert M Holewijn Suzanne Lensvelt Mare MA Zeebregts Clark J Reijnen Michel MPJ SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial Trials superficial femoral artery femoro-popliteal bypass endoluminal stentgraft peripheral arterial occlusive disease |
| title | SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial |
| title_full | SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial |
| title_fullStr | SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial |
| title_full_unstemmed | SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial |
| title_short | SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial |
| title_sort | surgical versus percutaneous bypass superb trial heparin bonded endoluminal versus surgical femoro popliteal bypass study protocol for a randomized controlled trial |
| topic | superficial femoral artery femoro-popliteal bypass endoluminal stentgraft peripheral arterial occlusive disease |
| url | http://www.trialsjournal.com/content/12/1/178 |
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