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BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3) : study protocol for a randomised controlled trial
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Hunt, Benjamin D., Popplewell, Matthew A., Davies, Huw, Meecham, Lewis, Jarrett, Hugh, Bate, Gareth, Grant, Margaret, Patel, Smitaa, Hewitt, Catherine, Andronis, L. (Lazaros) , Deeks, Jonathan J. and Bradbury, Andrew (2017) BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3) : study protocol for a randomised controlled trial. Trials, 18 (1). 224. doi:10.1186/s13063-017-1968-6 ISSN 1745-6215.
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WRAP-BAlloon-versus-Stenting-protocol-trial-Andronis-2017.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1401Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s13063-017-1968-6
Abstract
Background
Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources.
Methods
The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with ‘multilevel’ disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years.
| Item Type: | Journal Article | ||||||
|---|---|---|---|---|---|---|---|
| Subjects: | R Medicine > RD Surgery | ||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Ischemia -- Treatment, Stents (Surgery), Clinical trials | ||||||
| Journal or Publication Title: | Trials | ||||||
| Publisher: | Biomed Central | ||||||
| ISSN: | 1745-6215 | ||||||
| Official Date: | 19 May 2017 | ||||||
| Dates: |
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| Volume: | 18 | ||||||
| Number: | 1 | ||||||
| Article Number: | 224 | ||||||
| DOI: | 10.1186/s13063-017-1968-6 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||
| Date of first compliant deposit: | 23 October 2017 | ||||||
| Date of first compliant Open Access: | 23 October 2017 | ||||||
| Funder: | National Institute for Health Research (Great Britain) (NIHR) | ||||||
| Grant number: | Project number 13/81/02 |
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