Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading (NCT05003817) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
United Kingdom300 participantsStarted 2021-08-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8\*
. Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)#
. Complex PCI defined by the presence of at least one of the following criteria:
Exclusion criteria
. Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device)
. Contraindication to pLVAD insertion
. Inability to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called a 'Win Ratio' to measure outcomes — can you explain in plain terms what they're actually tracking and what a 'win' means for a patient like me?
2Since this is a Phase 3 trial focused on high-risk coronary intervention with left ventricular unloading, how does the level of risk in my specific case compare to the patients this study was designed for?
3The trial is active but no longer enrolling new participants — does that mean results might be available soon, and should I wait to hear those findings before deciding on my treatment approach?
4What is percutaneous left ventricular unloading, and how does having that support during a high-risk procedure compare to what I would receive under standard coronary intervention without it?
5Given my current condition, would you recommend pursuing standard treatment now rather than waiting for trial results, or do you think the approach being studied here could genuinely change the recommendation for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite hierarchical outcome analysed using a Win Ratio method.
Timeframe: Minimum 12-months of follow-up, up to 51 months