A trial to investigate whether a heart pump improves the safety and effectiveness of high-risk coronary artery stenting procedures

Phase 3

Active, not recruiting

Conditions: Ischaemic heart failure
Circulatory System
Ischaemic cardiomyopathy

Registration Number: ISRCTN17730734

Lead Sponsor: King's College London

Brief Summary: 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38410944/ (added 24/07/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 300

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 an 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:
3.1. Unprotected left main intervention in the presence of
3.1.1. An occluded dominant right coronary artery or
3.1.2. A left dominant circulation or
3.1.3. Disease involving the entire bifurcation (Medina 1,1,1 or 0,1,1)
4. Intended calcium modification (by rotational atherectomy, lithotripsy or laser)
4.1. In multiple vessels or
4.2. In the left mainstem or
4.3. In a final patent conduit or
4.4. Where the anatomic SYNTAX score is =32
5. Target vessel is a chronic total occlusion with a planned retrograde approach

Exclusion Criteria

Current exclusion criteria as of 23/02/2023:

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

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Previous exclusion criteria:

1. Cardiogenic shock or acute STEMI at randomization
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite hierarchical outcome of death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation (including prolongation of the index admission for bleeding and vascular complications) and periprocedural myocardial infarction analysed using a Win Ratio method between 1 and 4 years

Secondary Outcome Measures