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

Coronary Artery Disease Clinical Trial

— CHIP-BCIS3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003817
• Other study ID #: IRAS290599
• Secondary ID: 13059317730734
• Status: Recruiting
• Phase: Phase 3
• Start date: August 6, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Trial Manager
• Phone: 020 7927 2723
• Email: CHIP-BCIS3[@]LSHTM.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score = 8*

2. Severe left ventricular systolic dysfunction defined as a LVEF = 35% (or = 45% in the presence of severe mitral regurgitation)#

3. 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 (Medina1,1,1 or 0,1,1)
• Intended calcium modification (by rotational atherectomy, lithotripsy or laser) o inmultiplevesselsor
• 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:

1. Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device)

2. Contraindication to pLVAD insertion

3. Inability to give informed consent

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Percutaneous left ventricular unloading
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.

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (17)

Lead Sponsor

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Barts Heart Centre, London, Bristol Heart Institute, Freeman Hospital, Newcastle, Glenfield Hospital, Leicester, King's College Hospital, London, King's College London, Leeds General Infirmary, London School of Hygiene and Tropical Medicine, Morriston Hospital, Swansea, New Cross Hospital, Wolverhampton, Royal Sussex County Hospital, Royal Victoria Hospital, Belfast, St Thomas' Hospital, London, St. George's Hospital, London, The Queen Elizabeth Hospital, The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 4 years
Secondary	Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.	Analysis will include repeated occurrences of these events	Minimum 12-months of follow-up, up to 4 years
Secondary	Completeness of revascularisation measured by the change in anatomic BCIS-JS score		Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation
Secondary	Completeness of revascularisation measured by the change in anatomic SYNTAX score		Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation
Secondary	Major bleeding (BARC 3 or 5) using the Bleeding Academic Research Consortium (BARC) classification		Up to 90 days post-randomisation
Secondary	Vascular complication measured as the incidence of injury to a major artery or vein resulting in either major bleeding, tissue ischaemia/necrosis requiring percutaneous or surgical intervention, or death		At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation
Secondary	Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension		At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation
Secondary	Unplanned revascularisation		Up to 90 days post-randomisation
Secondary	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.	90 days and 1 year post-randomisation
Secondary	Resource utilisation and cost effectiveness measured by incremental costs		At 12-months post-randomisation
Secondary	Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)		At 12-months post-randomisation
Secondary	Resource utilisation and cost effectiveness measured by net monetary benefit		At 12-months post-randomisation