Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

NCT ID: NCT06274411

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-21
• Study Completion Date: 2026-12-01

Brief 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

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, bleeding, surgical revision and renal replacement therapy.

Conditions

ECMO; High-risk PCI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Standby cannulated ECMO

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Prophylactic ECMO

Intervention Type: PROCEDURE

Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.

Interventions

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.

Intervention Type: PROCEDURE

Prophylactic ECMO

Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Asia Heart Hospital

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role: collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Lanzhou Medical University

UNKNOWN

Sponsor Role: collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaotong Hou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaotong Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaotong Hou, MD

Role: CONTACT

xt.hou@ccmu.edu.cn

010-64456631

Facility Contacts

Liangshan Wang, MD

Role: primary

wangliangshanbam@sina.com

86-13811363372

Other Identifiers

KS2024014

Identifier Type: -

Identifier Source: org_study_id