Complex High-risk and Indicated PatientsNCT06713876
Long-term Outcomes of Patients Undergoing ECMO-assisted PCI
An observational study of Complex High-risk and Indicated Patients, run by Ling Tao, MD, PhD at 1 site in China.
Trial summary
Evidence regarding the long-term outcomes of patients undergoing Veno-arterial extracorporeal membrane oxygenator (VA-ECMO) assisted percutaneous coronary intervention (PCI) and the impact of the operator experience is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex High-risk and Indicated Patients
- What is being tested?
- VA-ECMO-assisted PCI
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 31 Jul 2025
- Phase
- Observational
- 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
Study population: Consecutive patients treated with VA-ECMO-assisted PCI
Who may be able to join
- Aged 18 years or older
- Coronary artery disease of the left main and/or multivessel disease
- Combined with severely impaired left ventricular ejection fraction (LVEF), defined as LVEF ≤ 35% or decompensated heart failure
- The heart team and the patient rejected CABG or OMT
- Exclusion criteria were VA-ECMO support applied for cardiogenic shock or extracorporeal cardiopulmonary resuscitation (ECPR)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes of Patients Undergoing Extracorporeal Membrane Oxygenator-assisted Percutaneous Coronary Intervention
Evidence regarding the long-term outcomes of patients undergoing Veno-arterial extracorporeal membrane oxygenator (VA-ECMO) assisted percutaneous coronary intervention (PCI) and the impact of the operator experience is limited.
The purpose of this retrospective single-center, observational registry in China is to investigate the long-term outcomes of patients undergoing VA-ECMO-assisted PCI and the impact of the operator experience.
Read the detailed description
In the past four decades, there has been a widespread percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Guidelines recommended that PCI is a reasonable option to improve survival, compared with medical therapy, in selected patients with low-to-medium anatomic complexity of CAD equally suitable for coronary artery bypass grafting (CABG); for complex and diffuse CAD, CABG was associated with a more significant clinical benefit. However, CABG is not always feasible due to patient preferences or the excess risk of perioperative morbidity and mortality. In selected patients with functionally significant multivessel disease (MVD) and LVEF ≤ 35% who are at high surgical risk or inoperable, PCI may be considered as an alternative to CABG. The recent 2024 European Society of Cardiology guidelines for the management of chronic coronary syndromes provided IIb B recommendation under such settings. However, such a subset of patients is considered at high risk for PCI complications due to the risk of hemodynamic collapse during balloon inflations or complex procedures.
Mechanical circulatory support (MCS) devices for elective high-risk PCI can provide hemodynamic support preventing hemodynamic failure during PCI. Several studies have suggested that intra aortic balloon pump (IABP) showed no significant benefits. Impella with a larger hemodynamic support also failed to demonstrate benefits, despite a tendency favoring the device. Venoarterial extracorporeal membrane oxygenation (VA -ECMO) is an alternative option for mechanical support, providing more extensive hemodynamic support in patients with potential or ongoing circulation failure. Initial reports on the use of VA-ECMO showed controversial results in the treatment of cardiogenic shock due to myocardial infarction. However, available evidence for the use of VA-ECMO in high-risk PCI has been restricted to retrospective small sizes; large-volume studies about the long-term outcome in this patient are limited.
ECMO requires a complex multidisciplinary approach and advanced technology. The potential benefits of hemodynamic support may be outweighed by the risk of device-associated complications, particularly bleeding and peripheral vascular events. Two studies have demonstrated that ECMO center experience may be associated with lower mortality in patients with cardiorespiratory failure. However, the relationship between operator experience and long-term outcomes post-VA-ECMO-assisted PCI in high-risk patients, and the ideal threshold to classify an operator as "experienced" have not been previously studied. Therefore, the aim of the present study was also to analyze the association between operator experience and one-year mortality post-VA-ECMO-assisted PCI.
- Conditions
- Complex High-risk and Indicated Patients
- Being tested
- VA-ECMO-assisted PCI
- Keywords
- Percutaneous Coronary Intervention, ECMO, high-risk PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA-ECMO-assisted PCIDevice
A total of 220 consecutive patients with VA-ECMO-assisted PCI will be enrolled. Data related to medical history, procedural characteristics, and outcomes were collected. Clinical follow-up will be conducted in the periprocedural and postoperative at 1 month, 1 year, 2 years, 3 years, 4 years, and 5 years.
| Study group | Role | What they receive |
|---|---|---|
| VA-ECMO-assisted PCI | Not described Receives: Device: VA-ECMO-assisted PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
Measured: 1 year
Secondary outcomes (6)
cardiac death
The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
Measured: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
myocardial infarction
The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
Measured: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
stroke
Including ischemic stroke and hemorrhagic stroke. The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
Measured: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
revascularization
Including target vessel revascularization and non-target vessel revascularization. The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
Measured: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
rehospitalization
The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
Measured: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
periprocedural complications
The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
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 posted3 Dec 2024
- Study start1 Aug 2016
- Primary completion30 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex High-risk and Indicated PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ling Tao, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ling Tao, MD, PhD, Xijing Hospital
- Investigators
- Ling Tao, M.D., Ph.D, Study chair, Xijing HospitalChao Gao, M.D., Ph.D., Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713876
- Sponsor's protocol ID
- KY20242366-C-1
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng A, Wang B, Fu G, Li C, Liu Y, Li F, Wang Q, Yin Z, Gao H, Gao C, Tao L. Long-Term Outcomes of Patients Undergoing Extracorporeal Membrane Oxygenator-Assisted High-Risk Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2025 Oct;106(4):2637-2644. doi: 10.1002/ccd.70098. Epub 2025 Aug 21.
PubMed 40842186
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Patients Undergoing Extracorporeal Membrane Oxygenator-assisted Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06713876
- Acronym / sponsor ID
- KY20242366-C-1
- Conditions
- Complex High-risk and Indicated Patients
- Keywords
- Percutaneous Coronary Intervention, ECMO, high-risk PCI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ling Tao, MD, PhDUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 3 Dec 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.
Evidence regarding the long-term outcomes of patients undergoing Veno-arterial extracorporeal membrane oxygenator (VA-ECMO) assisted percutaneous coronary intervention (PCI) and the impact of the operator experience is limited.
The purpose of this retrospective single-center, observational registry in China is to investigate the long-term outcomes of patients undergoing VA-ECMO-assisted PCI and the impact of the operator experience.
Detailed description
In the past four decades, there has been a widespread percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Guidelines recommended that PCI is a reasonable option to improve survival, compared with medical therapy, in selected patients with low-to-medium anatomic complexity of CAD equally suitable for coronary artery bypass grafting (CABG); for complex and diffuse CAD, CABG was associated with a more significant clinical benefit. However, CABG is not always feasible due to patient preferences or the excess risk of perioperative morbidity and mortality. In selected patients with functionally significant multivessel disease (MVD) and LVEF ≤ 35% who are at high surgical risk or inoperable, PCI may be considered as an alternative to CABG. The recent 2024 European Society of Cardiology guidelines for the management of chronic coronary syndromes provided IIb B recommendation under such settings. However, such a subset of patients is considered at high risk for PCI complications due to the risk of hemodynamic collapse during balloon inflations or complex procedures.
Mechanical circulatory support (MCS) devices for elective high-risk PCI can provide hemodynamic support preventing hemodynamic failure during PCI. Several studies have suggested that intra aortic balloon pump (IABP) showed no significant benefits. Impella with a larger hemodynamic support also failed to demonstrate benefits, despite a tendency favoring the device. Venoarterial extracorporeal membrane oxygenation (VA -ECMO) is an alternative option for mechanical support, providing more extensive hemodynamic support in patients with potential or ongoing circulation failure. Initial reports on the use of VA-ECMO showed controversial results in the treatment of cardiogenic shock due to myocardial infarction. However, available evidence for the use of VA-ECMO in high-risk PCI has been restricted to retrospective small sizes; large-volume studies about the long-term outcome in this patient are limited.
ECMO requires a complex multidisciplinary approach and advanced technology. The potential benefits of hemodynamic support may be outweighed by the risk of device-associated complications, particularly bleeding and peripheral vascular events. Two studies have demonstrated that ECMO center experience may be associated with lower mortality in patients with cardiorespiratory failure. However, the relationship between operator experience and long-term outcomes post-VA-ECMO-assisted PCI in high-risk patients, and the ideal threshold to classify an operator as "experienced" have not been previously studied. Therefore, the aim of the present study was also to analyze the association between operator experience and one-year mortality post-VA-ECMO-assisted PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VA-ECMO-assisted PCI | – | Device: VA-ECMO-assisted PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients treated with VA-ECMO-assisted PCI
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Coronary artery disease of the left main and/or multivessel disease
- Combined with severely impaired left ventricular ejection fraction (LVEF), defined as LVEF ≤ 35% or decompensated heart failure
- The heart team and the patient rejected CABG or OMT
- Exclusion criteria were VA-ECMO support applied for cardiogenic shock or extracorporeal cardiopulmonary resuscitation (ECPR)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VA-ECMO-assisted PCIA total of 220 consecutive patients with VA-ECMO-assisted PCI will be enrolled. Data related to medical history, procedural characteristics, and outcomes were collected. Clinical follow-up will be conducted in the periprocedural and postoperative at 1 month, 1 year, 2 years, 3 years, 4 years, and 5 years. | Device | VA-ECMO-assisted PCI |
Primary outcome
all-cause death
Time frame: 1 year
The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.
6 secondary outcomes
cardiac death
Time frame: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
myocardial infarction
Time frame: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
stroke
Time frame: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
revascularization
Time frame: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
rehospitalization
Time frame: 30 days, 1 year, 2 years, 3 years, 4 years, and 5 years
periprocedural complications
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 3 Dec 2024.
- Derived from this study: PubMed 40842186Cheng A, Wang B, Fu G, Li C, Liu Y, Li F, Wang Q, Yin Z, Gao H, Gao C, Tao L. Long-Term Outcomes of Patients Undergoing Extracorporeal Membrane Oxygenator-Assisted High-Risk Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2025 Oct;106(4):2637-2644. doi: 10.1002/ccd.70098. Epub 2025 Aug 21.
- Individual participant dataSharing planned: No
Related trials for Complex High-risk and Indicated Patients
Not yet recruitingObservational study
CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China
Coronary Artery Disease, High Risk PCI
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. This study is not recruiting at the moment.
Ling Tao, M.D., Ph.D study chair
Xijing Hospital
Chao Gao, M.D., Ph.D. study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex High-risk and Indicated Patients, run by Ling Tao, MD, PhD 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 5 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713876, which also lists 1 linked publication.
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 3 Dec 2024.