Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

NCT06274411 | Recruiting DMC

• 1 other identifier: KS2024014
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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

Conditions

ECMO; High-risk PCI

Keywords

ECMO; PCI

Outcome Measures

Primary Outcomes (1)

• Composite rate of 9 major adverse events

  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

  30 days

Secondary Outcomes (9)

• Post-procedural hemoglobin decline

  30 days

• Post-procedural platelet count decline

  30 days

• RBC transfusion rate

  30 days

• Serum interleukin-6 concentration

  30 days

• Duration of ECMO support

  30 days

Study Arms (2)

Standby cannulated ECMO

EXPERIMENTAL

For standby cannulated ECMO procedures, femoral cannulas are inserted either by percutaneous approach or surgical approach. The primed circuit is connected to the inserted ECMO cannulas, clamps are kept on circuit, and ECMO is on standby during PCI. When PCI cause hemodynamic instability, clamps on circuit are removed, and VA-ECMO is initiated to maintain maintain adequate systemic pressure and perfusion.

Procedure: Standby cannulated ECMO

Prophylactic ECMO

ACTIVE COMPARATOR

Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI. Femoral cannulas are inserted either by percutaneous approach or surgical approach. Following cannula placement, VA-ECMO is initiated to maintain adequate systemic pressure and perfusion during PCI.

Procedure: Prophylactic ECMO

Interventions

Standby cannulated ECMO PROCEDURE

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.

Standby cannulated ECMO

Prophylactic ECMO PROCEDURE

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

Prophylactic ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinicians decide to perform PCI during ECMO support.
• Age of ≥18
• 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)
• Informed consent

You may not qualify if:

• Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP \>90mmHg)
• Presence of moderate to severe aortic insufficiency
• Severe peripheral vascular disease
• creatinine≥4mg/dL
• Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN
• History of recent (within 1 month) stroke or TIA
• Abnormal coagulation(defined as platelet count ≤50000/mm3 or Fibrinogen ≤1.50g/L)
• Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Wuhan Asia Heart Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• The First Affiliated Hospital of Lanzhou Medical University: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Study Officials

• Xiaotong Hou, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaotong Hou, MD

CONTACT

010-64456631; xt.hou@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: February 23, 2024
• Study Start: March 21, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)