Trial reportTrials2017
BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial.
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- A systematic review of patient-reported outcome measures patients with chronic limb-threatening ischemia.Journal of vascular surgery · 2022Pooled it
- Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis.PloS one · 2022Pooled it
- Angioplasty versus stenting for iliac artery lesions.The Cochrane database of systematic reviews · 2020Pooled it
- Global vascular guidelines on the management of chronic limb-threatening ischemia.Journal of vascular surgery · 2019Guideline
- Plain balloon angioplasty +/- bare metal stenting versus drug-coated balloon angioplasty +/- bare metal stenting versus primary drug-eluting stenting in patients with chronic limb-threatening ischaemia: BASIL-3, an open-label, three-arm, randomised, multi-centre, phase 3 trial.Health technology assessment (Winchester, England) · 2026Trial
- Long-term mortality rate and clinical outcomes associated with femoro-popliteal drug-coated balloon angioplasty and drug-eluting stents in chronic limb-threatening ischaemia: an analysis of the BASIL-3 RCT.The British journal of surgery · 2025Trial
- Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.BMJ (Clinical research ed.) · 2025Trial
- Article
- BEST-CLI International Collaborative: planning a better future for patients with chronic limb-threatening ischaemia globally.The British journal of surgery · 2024Article
- Ambulatory Status Over Time after Revascularization in Patients with Chronic Limb-Threatening Ischemia.Journal of atherosclerosis and thrombosis · 2022Observational
- The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale.International journal of cardiology. Heart & vasculature · 2022Article
- Comprehensive Assessment of Current Management Strategies for Patients With Diabetes and Chronic Limb-Threatening Ischemia.Clinical diabetes : a publication of the American Diabetes Association · 2021Article
- Comparison of Clinical Outcomes in Patients Selected for Infra-Popliteal Bypass or Plain Balloon Angioplasty for Chronic Limb Threatening Ischemia Between 2009 and 2013.Vascular and endovascular surgery · 2020Article
- Single versus Multiple Vessel Endovascular Tibial Artery Revascularization for Critical Limb Ischemia: A Review of the Literature.The International journal of angiology : official publication of the International College of Angiology, Inc · 2020Review
- Paclitaxel-Coated Balloons and Stents for Lower Extremity Peripheral Arterial Disease Interventions: A Regulatory Perspective for the Practicing Clinician.Mayo Clinic proceedings · 2020Article
- Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease?Current cardiology reports · 2019Review
- Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia.European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery · 2019Article
- Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2019Article
- Interventions for lower extremity peripheral artery disease.Nature reviews. Cardiology · 2018Review
- The comparative efficacy of angiosome-directed and indirect revascularisation strategies to aid healing of chronic foot wounds in patients with co-morbid diabetes mellitus and critical limb ischaemia: a literature review.Journal of foot and ankle research · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSevere 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.
methodsThe 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. DISCUSSION: BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease.
trial registrationISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.