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| ID | Type | Description | Link |
|---|---|---|---|
| 130593 | Other Grant/Funding Number | NIHR HTA CET | |
| 17730734 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
| The Queen Elizabeth Hospital | OTHER |
| The Royal Bournemouth Hospital | OTHER |
| St. George's Hospital, London |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LV-unloading | Experimental | Participants in the elective unloading (intervention) group will have a percutaneous left ventricular unloading device (pLVAD) inserted at the start of the procedure, before the coronary intervention. Maximal support will be provided throughout the procedure, following which support will be weaned and the device removed should the patient remain haemodynamically stable. |
|
| Standard of Care | No Intervention | Participants in the control arm will receive the planned high-risk percutaneous coronary intervention as is the current standard of care without elective left ventricular unloading. Alternative mechanical circulatory support devices (such as the intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) will only be permitted in case of complications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous left ventricular unloading | Device | Percutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite hierarchical outcome analysed using a Win Ratio method. | Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction. | Minimum 12-months of follow-up, up to 51 months |
| Measure | Description | Time Frame |
|---|---|---|
| Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial injury. | Analysis will include repeated occurrences of these events | Minimum 12-months of follow-up, up to 51 months |
| Completeness of revascularisation measured by the change in anatomic BCIS-JS score |
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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:
Unprotected left main intervention in the presence of
Intended calcium modification (by rotational or orbital atherectomy, lithotripsy or laser)
Target vessel is a chronic total occlusion with planned retrograde approach
In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Divaka Perera | KCL, GSTT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38410944 | Background | Ryan M, Ezad SM, Webb I, O'Kane PD, Dodd M, Evans R, Laidlaw L, Khan SQ, Weerackody R, Bagnall A, Panoulas VF, Rahman H, Strange JW, Fath-Ordoubadi F, Hoole SP, Stables RH, Curzen N, Clayton T, Perera D; CHIP-BCIS3 Investigators. Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial. Circ Cardiovasc Interv. 2024 Mar;17(3):e013367. doi: 10.1161/CIRCINTERVENTIONS.123.013367. Epub 2024 Feb 27. | |
| 41910380 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2024 | Oct 29, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
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| OTHER |
| King's College Hospital NHS Trust | OTHER |
| King's College London | OTHER |
| Royal Victoria Hospital, Belfast | OTHER |
| Bristol Heart Institute | UNKNOWN |
| Barts Heart Centre, London | UNKNOWN |
| Glenfield Hospital, Leicester | OTHER |
| Morriston Hospital, Swansea | UNKNOWN |
| St Thomas' Hospital, London | OTHER |
| New Cross Hospital, Wolverhampton | UNKNOWN |
| Essex Cardiothoracic Centre, Basildon | UNKNOWN |
| Freeman Hospital, Newcastle | UNKNOWN |
| Golden Jubilee National Hospital, Glasgow | UNKNOWN |
| John Radcliffe Hospital, Oxford | UNKNOWN |
| Manchester Royal Infirmary | UNKNOWN |
| Royal Cornwall Hospital, Truro | UNKNOWN |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| Musgrove Park Hospital, Taunton | UNKNOWN |
| Royal Sussex County Hospital, Brighton | UNKNOWN |
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| Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year |
| Completeness of revascularisation measured by the change in anatomic SYNTAX score | Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year |
| Major bleeding using the Bleeding Academic Research Consortium (BARC 3 to 5) classification | At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up |
| Vascular complication measured using VARC criteria | Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year |
| Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension | Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year |
| Unplanned revascularisation | At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up |
| Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) | The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes. | At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up |
| Resource utilisation and cost effectiveness measured by incremental costs | At 12-months post-randomisation |
| Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs) | At 12-months post-randomisation |
| Resource utilisation and cost effectiveness measured by net monetary benefit | At 12-months post-randomisation |
| Acute kidney injury | Defined as prolongation hospital admission or readmission ≥ 24 hours with rise in creatinine to 200% of baseline value or need for new renal replacement therapy within 30 days of procedure | At 90 days post-randomisation |
| Serial cardiac troponin (T or I) levels | Measured by immunoassay | At baseline, 6 and 24 hours post-procedure |
| Length of stay | Measured by the duration of admission in complete days following the index PCI procedure and any subsequent planned staged PCI procedure | Up to a maximum of 1 year |
| Derived |
| Perera D, Ryan M, Ezad SM, Khan SQ, Webb I, O'Kane PD, Weerackody R, Dodd M, Kwok M, Laidlaw L, Van Dyck L, Wrigley B, Strange JW, Bagnall A, Fath-Ordoubadi F, Panoulas VF, Ladwiniec A, Davies JR, Chase A, Owens CG, Watkins S, Rahman H, Pareek N, Rathod K, Rawlins J, Evans R, Hoole SP, Stables RH, Curzen N, Clayton T; CHIP-BCIS3 Investigators. Left Ventricular Unloading in High-Risk Percutaneous Coronary Intervention. N Engl J Med. 2026 May 7;394(18):1779-1789. doi: 10.1056/NEJMoa2515704. Epub 2026 Mar 29. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |