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

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

Study Overview

• Status: Recruiting
• Conditions: High-risk PCI; ECMO
• Intervention / Treatment: Procedure: Standby cannulated ECMO; Procedure: Prophylactic ECMO

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotong Hou, MD; Phone Number: 010-64456631; Email: xt.hou@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: Liangshan Wang, MD; Phone Number: 86-13811363372; Email: wangliangshanbam@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Clinicians decide to perform PCI during ECMO support.
2. Age of ≥18
3. Patient presents with a compromised ejection fraction of less than 35% or at risk of hemodynamic deterioration, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of ≥33)
4. Informed consent

Exclusion Criteria:

1. Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP >90mmHg)
2. Presence of moderate to severe aortic insufficiency
3. Severe peripheral vascular disease
4. creatinine≥4mg/dL
5. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN
6. History of recent (within 1 month) stroke or TIA
7. Abnormal coagulation(defined as platelet count ≤50000/mm3 or Fibrinogen ≤1.50g/L)
8. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standby cannulated ECMO; For standby cannulated ECMO procedures, femoral cannulas are inserted either by percutaneous approach or surgical approach. The primed circuit is connected to the inserted ECMO cannulas, clamps are kept on circuit, and ECMO is on standby during PCI. When PCI cause hemodynamic instability, clamps on circuit are removed, and VA-ECMO is initiated to maintain maintain adequate systemic pressure and perfusion.	Procedure: Standby cannulated ECMO; Femoral cannulas are inserted and connected to the primed circuit. Clamps are kept on circuit, and ECMO is on standby during PCI. ECMO is initiated if needed.
Active Comparator: Prophylactic ECMO; Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI. Femoral cannulas are inserted either by percutaneous approach or surgical approach. Following cannula placement, VA-ECMO is initiated to maintain adequate systemic pressure and perfusion during PCI.	Procedure: Prophylactic ECMO; Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite rate of 9 major adverse events	included all-cause death, myocardial infraction, repeat revascularization, stroke, percutaneous coronary intervention failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of ECMO support	Time on ECMO support	30 days
Length of hospital stay	Time of hospitalization	30 days
Serum interleukin-6 concentration	Highest level of IL-6 during concentration	30 days
Post-procedural hemoglobin decline	The relative decrease in hemoglobin from the pre-procedural value to the nadir post-procedural value	30 days
Post-procedural platelet count decline	The relative decrease in platelet count from the pre-procedural value to the nadir post-procedural value	30 days
RBC transfusion rate	The percentage of patients who receive at least one unit of packed red blood cells	30 days
Hospitalization cost	The total cost until the discharge from the hospital	30 days
Use of intra-aortic balloon pump (IABP)	Unplanned initiation of IABP after randomization	30 days
Each component of the composite major adverse events	The incidence of all-cause death, myocardial infraction, repeat revascularization, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, or need for RRT	30 days

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: People's Hospital of Xinjiang Uygur Autonomous Region; Wuhan Asia Heart Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; The Second Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Lanzhou Medical University; People's Hospital of Guangxi Zhuang Autonomous Region
• Investigators: Principal Investigator: Xiaotong Hou, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 24, 2023
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PCI; ECMO
• Other Study ID Numbers: KS2024014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No