Back to results

Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading (CHIP-BCIS3)

Primary Purpose

Ischemic Heart Disease, Coronary Artery Disease

Status

Recruiting

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Percutaneous left ventricular unloading

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring percutaneous coronary intervention, percutaneous left ventricular unloading

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (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:

Cardiogenic shock or acute STEMI at randomisation
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

Sites / Locations

Guy's and St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LV-unloading

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Completeness of revascularisation measured by the change in anatomic SYNTAX score

Major bleeding (BARC 3 or 5) using the Bleeding Academic Research Consortium (BARC) classification

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

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

Unplanned revascularisation

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.

Resource utilisation and cost effectiveness measured by incremental costs

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

Resource utilisation and cost effectiveness measured by net monetary benefit

Full Information

NCT ID

NCT05003817

First Posted

July 21, 2021

Last Updated

September 27, 2023

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, London, King's College London, Royal Victoria Hospital, Belfast, Bristol Heart Institute, Leeds General Infirmary, Freeman Hospital, Newcastle, Barts Heart Centre, London, Glenfield Hospital, Leicester, Morriston Hospital, Swansea, St Thomas' Hospital, London, Royal Sussex County Hospital, New Cross Hospital, Wolverhampton

1. Study Identification

Unique Protocol Identification Number

NCT05003817

Brief Title

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

Acronym

CHIP-BCIS3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 6, 2021 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease, Coronary Artery Disease

Keywords

percutaneous coronary intervention, percutaneous left ventricular unloading

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LV-unloading

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Percutaneous left ventricular unloading

Intervention Description

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 Outcome Measure Information:

Title

Composite hierarchical outcome analysed using a Win Ratio method.

Description

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

Time Frame

Minimum 12-months of follow-up, up to 4 years

Secondary Outcome Measure Information:

Title

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

Description

Analysis will include repeated occurrences of these events

Time Frame

Minimum 12-months of follow-up, up to 4 years

Title

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 assessed up to 90 days post-randomisation

Title

Completeness of revascularisation measured by the change in anatomic SYNTAX score

Time Frame

Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation

Title

Major bleeding (BARC 3 or 5) using the Bleeding Academic Research Consortium (BARC) classification

Time Frame

Up to 90 days post-randomisation

Title

Time Frame

At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation

Title

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

Time Frame

At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation

Title

Unplanned revascularisation

Time Frame

Up to 90 days post-randomisation

Title

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

Description

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

Time Frame

90 days and 1 year post-randomisation

Title

Resource utilisation and cost effectiveness measured by incremental costs

Time Frame

At 12-months post-randomisation

Title

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

Time Frame

At 12-months post-randomisation

Title

Resource utilisation and cost effectiveness measured by net monetary benefit

Time Frame

At 12-months post-randomisation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 (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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Trial Manager

Phone

02079272723

CHIP-BCI3@LSHTM.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Matt Ryan

matthew.ryan@kcl.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Divaka Perera

Organizational Affiliation

KCL, GSTT

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guy's and St Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

R&D Office

R&D@gstt.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs