Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

ECMO Clinical Trial

— ESCORT  

Official title:

Standby Cannulated ECMO Versus Prophylactic ECMO for High-Risk Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274411
• Other study ID #: KS2024014
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Beijing Anzhen Hospital
• Contact: Xiaotong Hou, MD
• Phone: 010-64456631
• Email: xt.hou[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: March 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is indicated for a NON emergent PCI.

2. Patient presents with a compromised ejection fraction of less than 35%, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of >33).

3. Clinicians decide to perform PCI during ECMO support.

4. Informed consent

Exclusion Criteria:

1. ST elevation myocardial infraction.

2. Pre procedure cardiac arrest within 24 hours.

3. Subject in cardiogenic shock.

Related Conditions & MeSH terms

• ECMO

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite rate of 8 major adverse events	included all-cause death, myocardial infraction, repeat revascularization procedure, stroke, percutaneous coronary intervention failure, limb ischemia, bleeding, surgical revision and renal replacement therapy	30 days
Secondary	Platelet drop	Decrease in PLT during hospitalization	30 days
Secondary	Duration of ECMO support	Time on ECMO support	30 days
Secondary	Length of hospital stay	Time of hospitalization	30 days
Secondary	Hemoglobin drop	Decrease in Hb during hospitalization	30 days
Secondary	Serum interleukin-6 concentration	Highest level of IL-6 during concentration	30 days