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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

China1 site
  • Xijing Hospital

    Xi'an, Shaanxi, 710032

Other trials in China

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.

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 groups in NCT06713876
Study groupRoleWhat they receive
VA-ECMO-assisted PCINot described
Receives: Device: VA-ECMO-assisted PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all-cause death

    The outcome was defined according to the Mechanical Circulatory Support Academic Research Consortium definition.

    Measured: 1 year

Secondary outcomes (6)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted3 Dec 2024
  2. Study start1 Aug 2016
  3. Primary completion30 May 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

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)
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

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.

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