Controlled trial of High-risk coronary Intervention with Percutaneous left ventricular unloading (CHIP)

King's College London0 个研究点目标入组 300 人开始时间: 2020年10月30日最近更新: 2024年8月5日

适应症

试验速览

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

•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

•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
•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

发起方