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Clinical Trials in China / NCT06274411
Recruiting Not applicable

Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

NCT06274411 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Anzhen Hospital
Phase
Not applicable
Started
2025-03-21
Last updated
2026-05-13

Condition(s) studied

ECMOHigh-risk PCI

Investigational drug(s) / intervention(s)

Standby cannulated ECMOProphylactic ECMO

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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite rate of 9 major adverse events — 30 days
    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

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital Beijing Beijing Municipality Recruiting

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Other trials for the same condition

SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI Active, not recruiting
A Novel Strategy of ECMO Management Using Nafamostat for Regional Combined With Low Intensity Systematic Anticoagulation Recruiting
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI Recruiting
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI). Active, not recruiting
Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06274411 on ClinicalTrials.gov ↗ ← All trials in China