Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a heart attack. For most patients the risk of complications is low, but for some, there is a higher risk of their heart failing during the procedure. Heart failure is a serious complication which can need treatment with a life support machine and lead to major damage to the heart muscle or even death. These risks are greatest in patients with severely diseased heart arteries and those who already have weakened heart muscle. A new technology may be able to help with this problem. It consists of a small heart pump which is placed in the heart's main pumping chamber (the left ventricle, LV). This pump is known as a LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg and supports the heart muscle. It is removed at the end of the procedure or when the heart can pump safely on its own. Whilst this heart pump is promising, it comes with some risks of its own. These include bleeding and damage to the arteries in the legs. It is also expensive, costing £8,000 per operation. Currently, there is no strong evidence to guide the use of this device. The CHIP-BCIS3 study aims to determine whether these heart pumps are beneficial and cost-effective in patients receiving a stenting procedure who are at high-risk of complications.

NCT Number	NCT05003817
Lead Sponsor	Guy's and St Thomas' NHS Foundation Trust Collaborators: London School of Hygiene and Tropical Medicine, The Queen Elizabeth Hospital, The Royal Bournemouth Hospital, St. George's Hospital, London, King's College Hospital NHS Trust, King's College London, Royal Victoria Hospital, Belfast, Bristol Heart Institute, Barts Heart Centre, London, Glenfield Hospital, Leicester, Morriston Hospital, Swansea, St Thomas' Hospital, London, New Cross Hospital, Wolverhampton, Essex Cardiothoracic Centre, Basildon, Freeman Hospital, Newcastle, Golden Jubilee National Hospital, Glasgow, John Radcliffe Hospital, Oxford, Manchester Royal Infirmary, Royal Cornwall Hospital, Truro, Royal Brompton & Harefield NHS Foundation Trust, Musgrove Park Hospital, Taunton, Royal Sussex County Hospital, Brighton
Conditions	Ischemic Heart Disease, Coronary Artery Disease
Enrollment	300 participants
Start Date	2021-08-06
Primary Completion	2025-12-03 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-09