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Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the
Matthew Ryan1, Saad M Ezad1, Ian Webb2
1School of Cardiovascular and Metabolic Medicine & Sciences at the British Heart Foundation Centre of Research Excellence, King's College London, United Kingdom (M.R., S.M.E., H.R., D.P.).
Insights
This trial investigates if percutaneous left ventricular unloading reduces adverse events in high-risk coronary intervention patients. Results will guide treatment for complex coronary artery disease and impaired heart function.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- High-risk percutaneous coronary intervention (PCI) for complex coronary artery disease carries a significant risk of cardiogenic shock.
- Impaired left ventricular (LV) function exacerbates risks during PCI, potentially limiting revascularization quality.
- Percutaneous LV unloading is explored to mitigate adverse events, but lacks robust evidence and incurs costs.
Purpose of the Study:
- To evaluate the efficacy of elective percutaneous LV unloading versus standard care in high-risk PCI patients.
- To determine if LV unloading improves outcomes in patients with severe LV systolic dysfunction and extensive coronary artery disease.
- To assess the impact of LV unloading on a composite of major adverse cardiovascular events.
Main Methods:
- A prospective, multicenter, open-label randomized controlled trial (CHIP-BCIS3).
- Recruitment of patients with severe LV dysfunction, extensive coronary artery disease undergoing complex PCI (excluding cardiogenic shock/STEMI).
- Primary outcome: hierarchical composite of death, stroke, MI, hospitalization, and periprocedural MI analyzed by win ratio.
Main Results:
- 169 patients recruited from 21 UK NHS hospitals to date.
- Recruitment is ongoing, with completion expected in 2024.
- The study is powered to detect a hazard ratio of 0.62 with 150 events.
Conclusions:
- The CHIP-BCIS3 trial is actively recruiting patients for this important investigation.
- Findings will provide crucial evidence on the effectiveness of percutaneous LV unloading in high-risk PCI.
- The study aims to optimize patient outcomes and revascularization strategies in complex coronary disease.
Introduction:
Percutaneous coronary intervention for complex coronary disease is associated with a high risk of cardiogenic shock. This can cause harm and limit the quality of revascularization achieved, especially when left ventricular function is impaired at the outset. Elective percutaneous left ventricular unloading is increasingly used to mitigate adverse events in patients undergoing high-risk percutaneous coronary intervention, but this strategy has fiscal and clinical costs and is not supported by robust evidence.
Methods:
CHIP-BCIS3 (Controlled Trial of High-Risk Coronary Intervention With Percutaneous Left Ventricular Unloading) is a prospective, multicenter, open-label randomized controlled trial that aims to determine whether a strategy of elective percutaneous left ventricular unloading is superior to standard care (no planned mechanical circulatory support) in patients undergoing nonemergent high-risk percutaneous coronary intervention. Patients are eligible for recruitment if they have severe left ventricular systolic dysfunction, extensive coronary artery disease, and are due to undergo complex percutaneous coronary intervention (to the left main stem with calcium modification or to a chronic total occlusion with a retrograde approach). Cardiogenic shock and acute ST-segment-elevation myocardial infarction are exclusions. The primary outcome is a hierarchical composite of all-cause death, stroke, spontaneous myocardial infarction, cardiovascular hospitalization, and periprocedural myocardial infarction, analyzed using the win ratio. Secondary outcomes include completeness of revascularization, major bleeding, vascular complications, health economic analyses, and health-related quality of life. A sample size of 250 patients will have in excess of 80% power to detect a hazard ratio of 0.62 at a minimum of 12 months, assuming 150 patients experience an event across all follow-up.
Conclusions:
To date, 169 patients have been recruited from 21 National Health Service hospitals in the United Kingdom, with recruitment expected to complete in 2024.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05003817.
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