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Recruiting INTERVENTIONAL NCT06274411

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

Updated 8 times since 2024 Last updated: Apr 23, 2026 Started: Mar 21, 2025 Primary completion: Nov 1, 2026 Completion: Dec 1, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshotRecruiting~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Jun 2025 · 5 months · monthly snapshotRecruiting~Jun 2025 – ~Oct 2025 · 4 months · monthly snapshotRecruiting~Oct 2025 – ~May 2026 · 7 months · monthly snapshotRecruitingMay 4, 2026 – present · 3 months · daily APIRecruiting

Change History

8 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Oct 2025 — May 2026 [monthly]

    Recruiting NA

  3. Jun 2025 — Oct 2025 [monthly]

    Recruiting NA

  4. Jan 2025 — Jun 2025 [monthly]

    Recruiting NA

  5. Dec 2024 — Jan 2025 [monthly]

    Recruiting NA

Show 3 earlier versions
  1. Sep 2024 — Dec 2024 [monthly]

    Recruiting NA

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  3. 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

Sponsor contact:
  • 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
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations