Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinicians decide to perform PCI during ECMO support.
• Age of ≥18
• 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)
• Informed consent
Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiaotong Hou, MD
xt.hou@ccmu.edu.cn
010-64456631
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 176
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Lanzhou Medical University, The First Affiliated Hospital of Zhengzhou University, People's Hospital of Guangxi Zhuang Autonomous Region, Wuhan Asia Heart Hospital, The First Hospital of Jilin University, First Affiliated Hospital of Harbin Medical University, First Hospital of China Medical University, Zhongshan People's Hospital, Guangdong, China, People's Hospital of Xinjiang Uygur Autonomous Region
Leads: Beijing Anzhen Hospital