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

Study acronym: CHIP-BCIS3
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Jun 30, 2026 to Dec 31, 2026v9
  2. Eligibility criteria revised
    • Secondary endpoints: 11 to 14
    • Collaborators revised (22)
    v8
  3. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Jun 30, 2025 to Dec 3, 2025
    • Site details revised
    • Collaborators: 16 to 22
    • Publications: details revised at 1 of 3 entries
  4. Enrollment target: 250 to 300
    • Eligibility criteria expanded, about 4 words
    v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria expanded, about 9 words
    • Collaborators: 7 to 16
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jun 2025 to Jun 30, 2025
    • Study completion date: Jun 2026 to Jun 30, 2026
    • Start date changed from estimate of Aug 2021 to Aug 6, 2021
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Ischemic Heart Disease, Coronary Artery Disease
Related terms Coronary Artery Disease, Myocardial Ischemia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov