Actively Recruiting
Standby Cannulated ECMO Versus Prophylactic ECMO in Patients Undergoing High-Risk Percutaneous Coronary Intervention
Led by Beijing Anzhen Hospital · Updated on 2026-05-13
176
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
W
Wuhan Asia Heart Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two strategies of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support during high-risk percutaneous coronary intervention (PCI) in patients with complex coronary artery disease or severely reduced heart function. The study aims to find out whether standby cannulated ECMO, where ECMO is initiated only if needed, improves outcomes compared to prophylactic ECMO, which is started before PCI. This trial addresses the challenge that ECMO support may cause complications like bleeding or limb ischemia, and some patients may not require ECMO during PCI. Participants will be randomly assigned to one of two groups: standby cannulated ECMO or prophylactic ECMO. In the standby group, femoral cannulas are inserted and connected to a primed ECMO circuit with clamps on; ECMO support is activated only if hemodynamic instability occurs during PCI. In the prophylactic group, ECMO is initiated immediately after cannula placement before PCI begins to maintain blood pressure and organ perfusion. Both approaches use either percutaneous or surgical insertion of femoral cannulas. During the trial, researchers will monitor participants for 30 days after PCI to track a combined rate of nine major adverse events including death, heart attack, stroke, bleeding, and others. Secondary measures include blood counts, inflammatory markers, duration of ECMO use, hospital stay length, costs, and need for additional heart support devices. The study enrolls adults aged 18 or older scheduled for high-risk PCI, with follow-up assessments to evaluate safety and clinical outcomes.
CONDITIONS
Brief Title
Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Doctors have decided PCI with ECMO support is needed
- Age 18 years or older
- Patient has severely reduced heart function (ejection fraction less than 35%), or is at risk of heart instability, or has complex 3-vessel coronary disease, or unprotected left main artery involvement
- Patient or legal representative agrees and gives informed consent
You will not qualify if you...
- Patient is in cardiogenic shock requiring medication or mechanical support to maintain blood pressure
- Moderate to severe aortic valve leakage
- Severe peripheral vascular disease
- Kidney failure with creatinine level 4 mg/dL or higher
- Liver problems with enzymes or bilirubin elevated three times above normal
- Stroke or transient ischemic attack (TIA) within the past month
- Abnormal blood clotting with low platelet count or low fibrinogen
- Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or history of heparin-induced low platelets
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day for PCI and ECMO support during the procedure
Participants undergo high-risk percutaneous coronary intervention (PCI) supported by either standby cannulated ECMO, where ECMO is initiated if needed during PCI, or prophylactic ECMO, where ECMO support is started before PCI.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for 30 days after the procedure to assess for major adverse events and recovery.
Approximately 3 follow-up visits (in-person or remote)
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
X
Xiaotong Hou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here