Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

Not Applicable

Recruiting

• Conditions: ECMO; High-risk PCI

• Registration Number: NCT06274411
• Lead Sponsor: Beijing Anzhen Hospital

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.

Study Timeline

• Study First Submitted: 2023-12-24
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-23
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Study Start: 2024-12-01
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite rate of 9 major adverse events	30 days	included all-cause death, myocardial infraction, repeat revascularization procedure, stroke, percutaneous coronary intervention failure, limb ischemia, bleeding, surgical revision and renal replacement therapy

Secondary Outcome Measures

Name	Time	Method
Platelet drop	30 days	Decrease in PLT during hospitalization
Hemoglobin drop	30 days	Decrease in Hb during hospitalization
RBC transfusion rate	30 days
Serum interleukin-6 concentration	30 days	Highest level of IL-6 during concentration
Duration of ECMO support	30 days	Time on ECMO support
Length of hospital stay	30 days	Time of hospitalization
Hospitalization cost	30 days

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China