Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

Last updated: November 14, 2024
Sponsor: Beijing Anzhen Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standby cannulated ECMO

Prophylactic ECMO

Clinical Study ID

NCT06274411
KS2024014
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 ofhemodynamic deterioration, or intervention on the last patent coronary conduit or anunprotected left main artery, or complex 3-vessel disease (SYNTAX score of ≥33)

  4. Informed consent

Exclusion

Exclusion Criteria:

  1. Subject in cardiogenic shock(need inotrope, pressor or mechanical support tomaintain 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 documentedheparin induced thrombocytopenia.

Study Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: Standby cannulated ECMO
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Beijing Anzhen Hospital

    Beijing, Beijing 100029
    China

    Active - Recruiting

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