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Active, Not Recruiting

NCT Number: NCT05003817

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

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

Treatment and study plan

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.

Primary outcomes

  1. Composite hierarchical outcome analysed using a Win Ratio method.

    Time frame: Minimum 12-months of follow-up, up to 51 months

    Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.

Secondary outcomes

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

    Time frame: Minimum 12-months of follow-up, up to 51 months

    Analysis will include repeated occurrences of these events

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

    Time frame: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year

  3. Completeness of revascularisation measured by the change in anatomic SYNTAX score

    Time frame: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year

  4. Major bleeding using the Bleeding Academic Research Consortium (BARC 3 to 5) classification

    Time frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up

  5. Vascular complication measured using VARC criteria

    Time frame: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year

  6. Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension

    Time frame: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year

  7. Unplanned revascularisation

    Time frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up

  8. Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)

    Time frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up

    The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes.

  9. Resource utilisation and cost effectiveness measured by incremental costs

    Time frame: At 12-months post-randomisation

  10. Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)

    Time frame: At 12-months post-randomisation

  11. Resource utilisation and cost effectiveness measured by net monetary benefit

    Time frame: At 12-months post-randomisation

  12. Acute kidney injury

    Time frame: At 90 days post-randomisation

    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

  13. Serial cardiac troponin (T or I) levels

    Time frame: At baseline, 6 and 24 hours post-procedure

    Measured by immunoassay

  14. Length of stay

    Time frame: Up to a maximum of 1 year

    Measured by the duration of admission in complete days following the index PCI procedure and any subsequent planned staged PCI procedure

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

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

Registry information

Acronym: CHIP-BCIS3

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 12, 2021
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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