The BASIL-3 Trial: Balloon vs. Stenting in Severe Ischaemia of the Leg-3

Not Applicable

• Conditions: Severe limb ischaemia due to femoro-popliteal disease; Circulatory System; Peripheral vascular disease, unspecified

• Registration Number: ISRCTN14469736
• Lead Sponsor: niversity of Birmingham

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28526046 protocol

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-22
• Last Update Posted: 28 August 2023
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 481

Inclusion Criteria

1. Aged 18 years or over
2. Have severe limb ischaemia due to femoro-popliteal, with or without infra-popliteal, peripheral artery disease
3. Be judged by the responsible clinicians (consultant vascular surgeon, interventional radiologist, diabetologist) working as part of a multidisciplinary team to require early endovascular femoro-popliteal, with or without infra-popliteal revascularisation in addition to best medical treatment, foot and wound care
4. Have adequate ‘inflow’ to support all possible trial revascularisation strategies
5. Be judged suitable for all possible trial revascularisation strategies following diagnostic imaging and a formal (documented) discussion by a multi-disciplinary team meeting

Exclusion Criteria

1. Have an anticipated life expectancy <6 months
2. Are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity [Scotland] Act 2000)
3. Are a non-English speaker where translation facilities are insufficient to guarantee informed consent
4. Are judged unsuitable for any of the revascularisation strategies being evaluated

Study & Design

• Study Type: Interventional
• Study Design: Not specified