ECMOECMO-READYNCT06274411
Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
A study testing Standby cannulated ECMO and Prophylactic ECMO in people with ECMO and High-risk PCI, run by Beijing Anzhen Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECMO, High-risk PCI
- What is being tested?
- Standby cannulated ECMO and Prophylactic ECMO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Liangshan Wang, MD, 86-13811363372, wangliangshanbam@sina.com
About this study
Official title: Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
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
Read the 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, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy.
- Conditions
- ECMO, High-risk PCI
- Being tested
- Standby cannulated ECMO, Prophylactic ECMO
- Keywords
- ECMO, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standby cannulated ECMOProcedure or surgery
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 ECMOProcedure or surgery
Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Prophylactic ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (9)
Post-procedural hemoglobin decline
The relative decrease in hemoglobin from the pre-procedural value to the nadir post-procedural value
Measured: 30 days
Post-procedural platelet count decline
The relative decrease in platelet count from the pre-procedural value to the nadir post-procedural value
Measured: 30 days
RBC transfusion rate
The percentage of patients who receive at least one unit of packed red blood cells
Measured: 30 days
Serum interleukin-6 concentration
Highest level of IL-6 during concentration
Measured: 30 days
Duration of ECMO support
Time on ECMO support
Measured: 30 days
Length of hospital stay
Time of hospitalization
Measured: 30 days
Hospitalization cost
The total cost until the discharge from the hospital
Measured: 30 days
Use of intra-aortic balloon pump (IABP)
Unplanned initiation of IABP after randomization
Measured: 30 days
Each component of the composite major adverse events
The incidence of all-cause death, myocardial infraction, repeat revascularization, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, or need for RRT
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start21 Mar 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMOStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital, First Affiliated Hospital of Harbin Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, People's Hospital of Guangxi Zhuang Autonomous Region, The First Affiliated Hospital of Lanzhou Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
- Investigators
- Xiaotong Hou, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274411
- Sponsor's protocol ID
- KS2024014
- Acronym
- ECMO-READY
- Status last verified
- May 2026
- First submitted
- 24 Dec 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06274411
- Acronym / sponsor ID
- ECMO-READY / KS2024014
- Conditions
- ECMO, High-risk PCI
- Keywords
- ECMO, PCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Wuhan Asia Heart Hospital, First Affiliated Hospital of Harbin Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, People's Hospital of Guangxi Zhuang Autonomous Region, The First Affiliated Hospital of Lanzhou Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, The Second Affiliated Hospital of Harbin Medical University
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standby cannulated ECMO | Experimental | Procedure: Standby cannulated ECMOFor 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. |
| Prophylactic ECMO | Active comparator | Procedure: Prophylactic ECMOProphylactic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standby cannulated ECMOFemoral 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. | Procedure or surgery | Standby cannulated ECMO |
| Prophylactic ECMOProphylactic ECMO procedures are performed in the catheterization laboratory before PCI. | Procedure or surgery | Prophylactic ECMO |
Primary outcome
Composite rate of 9 major adverse events
Time frame: 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
9 secondary outcomes
Post-procedural hemoglobin decline
Time frame: 30 days
Post-procedural platelet count decline
Time frame: 30 days
RBC transfusion rate
Time frame: 30 days
Serum interleukin-6 concentration
Time frame: 30 days
Duration of ECMO support
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Hospitalization cost
Time frame: 30 days
Use of intra-aortic balloon pump (IABP)
Time frame: 30 days
Each component of the composite major adverse events
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaotong Hou, MD principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standby cannulated ECMO and Prophylactic ECMO in people with ECMO and High-risk PCI, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaotong Hou, MD (010-64456631, xt.hou@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite rate of 9 major adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.