BASIL-2: Bypass v Angioplasty in Severe Ischaemia of the Leg - 2

Not Applicable

Completed

• Conditions: Severe ischaemia of the lower limb due to infrageniculate arterial disease; Circulatory System

• Registration Number: ISRCTN27728689
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26739146 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37116524/ (added 02/05/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-12
• Study Completion: 2023-04-30
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

1. Have Severe Limb Ischaemia (SLI) due to infra-popliteal (IP), with or without femoro-popliteal (FP) disease
2. Be judged by the responsible clinicians (consultant vascular surgeon (VS), interventional radiologist (IR), diabetologists) working as part of a multi-disciplinary team (MDT) to require early infra-popliteal (IP), with or without femoro-popliteal (FP), revascularisation in addition to Best Medical Treatment (BMT), foot and wound care
3. Have Aorto-Iliac (AI) ?inflow? adequate to support Vein Bypass (VB) and Best Endovascular Treatment (BET) (if not, then patients can be randomised after a successful AI procedure which can be either surgical or endovascular)
4. Be judged suitable for both Vein Bypass and Best Endovascular Treatment following diagnostic imaging and a formal (documented) discussion by consultant vascular surgeon and interventional radiologist in a properly constituted multi-disciplinary team meeting

Exclusion Criteria

Patients will be excluded if they:
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 either of the two revascularisation strategies by the responsible consultant VS and IR

Study & Design

• Study Type: Interventional
• Study Design: Not specified