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

NCT05003817 | Active Not Recruiting Phase 3 DMC

• 3 other identifiers: IRAS29059913059317730734
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Heart Disease; Coronary Artery Disease

Keywords

percutaneous coronary intervention; percutaneous left ventricular unloading

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial injury.

  Minimum 12-months of follow-up, up to 51 months

• Completeness of revascularisation measured by the change in anatomic BCIS-JS score

  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

Study Arms (2)

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.

Device: Percutaneous left ventricular unloading

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.

Interventions

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.

LV-unloading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• an occluded dominant right coronary artery, or
• a left dominant circulation, or
• disease involving the entire bifurcation (Medina 1,1,1 or 0,1,1)
• Intended calcium modification (by rotational or orbital atherectomy, lithotripsy or laser)
• in multiple vessels or
• in the left main stem, or
• in a final patent conduit, or
• where the anatomic SYNTAX score is ≥32
• 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.
• Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF.

You may not qualify if:

• 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
• Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: collaborator
• The Queen Elizabeth Hospital: collaborator
• The Royal Bournemouth Hospital: collaborator
• St. George's Hospital, London: collaborator
• King's College Hospital NHS Trust: collaborator
• King's College London: collaborator
• Royal Victoria Hospital, Belfast: collaborator
• Bristol Heart Institute: collaborator
• Barts Heart Centre, London: collaborator
• Glenfield Hospital, Leicester: collaborator
• Morriston Hospital, Swansea: collaborator
• St Thomas' Hospital, London: collaborator
• New Cross Hospital, Wolverhampton: collaborator
• Essex Cardiothoracic Centre, Basildon: collaborator
• Freeman Hospital, Newcastle: collaborator
• Golden Jubilee National Hospital, Glasgow: collaborator
• John Radcliffe Hospital, Oxford: collaborator
• Manchester Royal Infirmary: collaborator
• Musgrove Park Hospital, Taunton: collaborator
• Royal Cornwall Hospital, Truro: collaborator
• Guy's and St Thomas' NHS Foundation Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Royal Sussex County Hospital, Brighton: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38410944 BACKGROUND

• 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 Mar 29. doi: 10.1056/NEJMoa2515704. Online ahead of print.

  PMID: 41910380 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Divaka Perera

  KCL, GSTT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 12, 2021
• Study Start: August 6, 2021
• Primary Completion: December 3, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

GB (1)