Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention (ECMO-READY)
Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
Sponsor: Beijing Anzhen Hospital
A observational or N/A phase clinical study on ECMO and High-risk PCI, this trial is actively recruiting participants. The trial is conducted by Beijing Anzhen Hospital and has accumulated 8 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention (PCI) with hemodynamic support may be feasible for these high-risk patients. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be used to provide hemodynamic support during high-risk PCI procedures. However, ECMO might increase the rates of severe complications, such as bleeding and limb ischemia. Additionally, some patients might not need the support of ECMO. In this context, investigators propose a standby cannulated ECMO strategy, in which femoral cannulas are inserted and connected to primed circuit, and ECMO is initiated when needed. Therefore, investigators will conduct a prospective randomized clinical trial to compare outcomes between standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk PCI. Investigators will randomly assign 176 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease or severely depressed left ventricular function to standby cannulated ECMO group (n=88) or prophylactic ECMO (n=88). The primary end point was the 30-day incidence of major adverse events, including all-cause death, myocardial infraction, any repeat revascularization procedure, stroke, PCI failure, limb ischemia, major...
Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention (PCI) with hemodynamic support may be feasible for these high-risk patients. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be used to provide hemodynamic support during high-risk PCI procedures. However, ECMO might increase the rates of severe complications, such as bleeding and limb ischemia. Additionally, some patients might not need the support of ECMO. In this context, investigators propose a standby cannulated ECMO strategy, in which femoral cannulas are inserted and connected to primed circuit, and ECMO is initiated when needed. Therefore, investigators will conduct a prospective randomized clinical trial to compare outcomes between standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk PCI. Investigators will randomly assign 176 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease or severely depressed left ventricular function to standby cannulated ECMO group (n=88) or prophylactic ECMO (n=88). The primary end point was the 30-day incidence of major adverse events, including all-cause death, myocardial infraction, any repeat revascularization procedure, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy.
Status Flow
Change History
8 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: NA → None
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Oct 2025 — May 2026 [monthly]
Recruiting NA
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Jun 2025 — Oct 2025 [monthly]
Recruiting NA
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Jan 2025 — Jun 2025 [monthly]
Recruiting NA
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Dec 2024 — Jan 2025 [monthly]
Recruiting NA
▶ Show 3 earlier versions
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Sep 2024 — Dec 2024 [monthly]
Recruiting NA
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Jul 2024 — Sep 2024 [monthly]
Recruiting NA
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Mar 2024 — Jul 2024 [monthly]
Recruiting NA
First recorded
Eligibility Summary
The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is : • If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI
Contact Information
- Beijing Anzhen Hospital
- Chinese Academy of Medical Sciences, Fuwai Hospital
- First Affiliated Hospital of Harbin Medical University
- People's Hospital of Guangxi Zhuang Autonomous Region
- People's Hospital of Xinjiang Uygur Autonomous Region
- The First Affiliated Hospital of Lanzhou Medical University
- The Second Affiliated Hospital of Harbin Medical University
- Wuhan Asia Heart Hospital
For direct contact, visit the study record on ClinicalTrials.gov .