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

Plain English Summary

Background and study aims
Severe limb ischaemia (SLI) is a growing problem in the UK, with one in every 1000-2000 people being diagnosed every year. SLI is a serious condition in which the arteries supplying limbs (most often the legs) with blood become narrowed or blocked due to the build-up of fatty substances (plaque). This often occurs around the knee in the femoral and popliteal arteries (femoropopliteal disease), which means that the lower parts of the limb (such as the feet) do not receive adequate blood supply (vascularisation). In SLI, small injuries to the feet are unable to heal, as they are not being supplied with enough oxygen rich blood. If left untreated, this can lead to ulcers, gangrene and ultimately death of the limb (necrosis). Once the limb “dies” the only available course of action is amputation, which can cause the sufferer a great deal of emotional distress. In recent years, more and more patients are undergoing surgery to improve blood supply to the leg (revascularisation) before amputation becomes the only option. An angioplasty is a common procedure in which a thin tube (catheter) is placed in the narrowed blood vessel. A small balloon on the tip of the catheter is gradually inflated to reopen the artery and flatten the blockage against the artery wall. In some cases, the surgeon may also insert a mesh-like tube (stent) into the artery to keep it open. These techniques are known as endovascular, as they take place inside the artery. In recent years, new techniques have been developed with incorporate drugs designed to stop the blockages coming back. These techniques can be very expensive however, and more research is needed to find out whether they are more effective in the long-term than traditional procedures. The aim of this study is to compare the effectiveness and cost-effectiveness of new endovascular techniques using drugs with traditional methods.

Who can participate?
Adults with severe limb ischaemia due to femoropopliteal disease, who are suitable for early revascularisation.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are given a plain balloon angioplasty (traditional method), in which a bare metal stent (stent without a coating) is also inserted if required. For those in the second group, the balloon used in the angioplasty procedure is coated in a drug (drug-coated balloon angioplasty) designed to prevent cells from multiplying (cell proliferation) and re-blocking the artery. During the angioplasty procedure, the medication on the balloon surface is deposited on the artery wall when the balloon inflates. Those in the third group have a drug-eluting stent (DES) placed in the artery, which is a stent that is coated in a drug that blocks cell proliferation. After their procedures, patients in all three groups are monitored to find out whether having the endovascular procedure has prevented the need for amputation.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
November 2015 to August 2023

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Suzanne Lockyer, BASIL-3@trials.bham.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University of Birmingham
University/education

Department of Cardiovascular Medicine
Medical School
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

25/02/2025: Publication reference added.
12/09/2024: The intention to publish date was changed from 24/04/2024 to 31/12/2024.
18/08/2023: The following changes have been made:
1. Ethics approval was added.
2. The publication and dissemination plan was changed.
3. The intention to publish date was changed from 30/11/2023 to 24/04/2024.
16/02/2023: IPD sharing statement added.
16/01/2023: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2020 to 31/08/2021.
2. The overall trial end date has been changed from 30/11/2022 to 31/08/2023 and the plain English summary updated accordingly.
3. The final enrolment number has been added.
4. The trial website has been added.
5. The IRAS number has been added.
6. The public contact has been changed.
04/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/09/2019 to 30/09/2020.
2. The overall end date was changed from 01/06/2021 to 30/11/2022.
3. The intention to publish date was changed from 31/05/2021 to 30/11/2023.
4. The plain English summary was updated to reflect these changes.
5. The target number of participants was changed from 861 to 480.
02/04/2019: The condition has been changed from "Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis" to "Severe limb ischaemia due to femoro-popliteal disease" following a request from the NIHR.
08/03/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/02/2019 to 01/09/2019.
2. The overall trial end date was changed from 15/02/2019 to 01/06/2021.
22/05/2017: Publication reference added.