Coronary Artery DiseaseNCT04045873
PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI
A study testing extracorporeal membrane oxygenation in people with Coronary Artery Disease and Heart Failure, run by Xijing Hospital.
Trial summary
To determine whether hemodynamic support combining VA-ECMO with IABP could mitigate the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs), compared with IABP support alone, in patients undergoing elective and high-risk PCI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Heart Failure
- What is being tested?
- extracorporeal membrane oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 years to 85 years who meet any one of the following criteria
- Unprotected left main coronary artery disease with severe LV dysfunction (EF<35% or NYHA grade Ⅲ and Ⅳ).
- Unprotected left main coronary artery disease without severe LV dysfunction (LVEF>35% or NYHA Ⅰ and Ⅱ) must meet at least two of the complex procedure criteria (see Section II below).
- 3-vessel disease with severe LV dysfunction (EF<35% or NYHA grade Ⅲ and Ⅳ) must meet at least two of the complex procedure criteria (see Section II below).
- Criteria Defining a Complex Procedure
- Bifurcation requiring PCI in two branches (including PTCA or stenting).
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- Calcification requiring atherectomy.
- Tortuosity requiring device assistance.
- Difficult CTO（J-CTO score≥2）.
Who cannot join
- Acute myocardial infarction within the previous 48 hours.
- Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
- Cardiogenic shock.
- Complications of acute myocardial infarction (including ventricular septal defect, severe mitral regurgitation, and intractable ventricular arrhythmias).
- Contraindications to IABP or ECMO use, including significant iliac or femoral arterial disease and more than mild aortic regurgitation as seen on echocardiography.
- Bleeding diathesis or warfarin therapy with an international normalized ratio greater than 2.5.
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- Active internal bleeding (including menstruation) within the past month.
- Recent ischemic stroke within the past month diagnosed by CT or MRI.
- Previous hemorrhagic stroke diagnosed by CT or MRI.
- Allergy to aspirin, clopidogrel, heparin, ticagrelor or glycoprotein IIb/ IIIa inhibitors; thrombocytopenia.
- Pregnancy.
- Current enrollment in any other study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Randomized Clinical Trial of Hemodynamic Support With ECMO and IABP Versus IABP Alone, in Complex High-risk Patients Undergoing Elective PCI(PIONEER Trial)
To determine whether hemodynamic support combining VA-ECMO with IABP could mitigate the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs), compared with IABP support alone, in patients undergoing elective and high-risk PCI.
Read the detailed description
Percutaneous Coronary Intervention (PCI) supported by mechanical circulatory device may be a viable alternative for these patients with complex coronary artery disease combined with multiple comorbidities and poor hemodynamics. Extracorporeal Membrane Oxygenation (ECMO) can direct blood flow out of the body, oxygenate it, and then return it, to either completely or partially replace the function of the heart and lungs, and potentially increase the likelihood of functional recovery. Limitations of ECMO include lack of direct LV unloading, and increased LV afterload with subsequent LV overload, which in turn can increase myocardial oxygen demand and therefore limit any cardioprotective benefits . Measures to concurrently decrease LV afterload during ECMO, such as use of an Intra-Aortic Balloon Pump (IABP), may in theory offset some of the disadvantages of ECMO. To date, ECMO has most commonly been used in patients suffering from cardiac arrest and cardiogenic shock . As far as we are aware, there exist very limited reported data from monocentric observational studies and individual case reports on the use of ECMO for elective, high-risk PCI in the literature . More importantly, no previous randomized studies to evaluate the safety and efficacy of a strategy combining VA-ECMO and IABP during high-risk PCI have been conducted to date. Most importantly, the strategy of combined VA-ECMO and IABP has never been investigated in any randomized trial that we could find.
- Conditions
- Coronary Artery Disease, Heart Failure
- Being tested
- extracorporeal membrane oxygenation
- Keywords
- Complex high-risk patients, Percutaneous coronary intervention, Extracorporeal membrane oxygenation, Intra-aortic balloon pump
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal membrane oxygenationDevice
Also called intra-aortic balloon pump
The VA-ECMO procedure will be performed by femoral artery access, and the IABP will then be implanted in the contralateral femoral artery.
| Study group | Role | What they receive |
|---|---|---|
| ECMO plus IABP | Experimental | Not described Receives: Device: extracorporeal membrane oxygenation |
| IABP | Experimental | Not described Receives: Device: extracorporeal membrane oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy end point is the composite rate of MACCE at peri-procedure, in-hospital, or within a 30-day follow-up post-discharge.
The composite primary end point components include angiographic failure rates of PCI, all-cause death, myocardial infarction, stroke or transient ischemic attack, any repeat revascularization procedure, acute renal insufficiency, major vascular complications, severe intraprocedural hypotension requiring therapy, cardiopulmonary resuscitation, or ventricular tachycardia requiring cardioversion.
Measured: 30 days
Secondary outcomes (10)
The rate of complete revascularization
Measured: intra-procedure
intra-procedure hemodynamics
Measured: intra-procedure
vascular access site and access-related complications
Measured: intra-procedure
major or life-threatening or disabling bleeding
Measured: 30 days
stroke or transient ischemic attack
Measured: 30 days
acute kidney injury
Measured: 30 days
MACCE at 6 months
Measured: 6 months
MACCE at 1 year
Measured: 1 year
MACCE at 2 years
Measured: 2 years
MACCE at 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study startDec 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing 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
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Bethune International Peace Hospital, Beijing Anzhen Hospital, The Second Affiliated Hospital of Harbin Medical University, The General Hospital of Northern Theater Command
- Responsible party
- Sponsor
- Investigators
- Ling Tao, MD, PhD, Principal investigator, Xijing HospitalChunguang Qiu, MD, PhD, Study director, The First Affiliated Hospital of Zhengzhou UniversityLeisheng Ru, MD, PhD, Study director, Bethune International Peace HospitalJinghua Liu, MD, PhD, Study director, Beijing Anzhen HospitalBo Yu, MD, PhD, Study director, The Second Affiliated Hospital of Harbin Medical UniversityQuanming Jing, MD, PhD, Study director, The General Hospital of Northern Theater CommandChengxiang Li, MD, PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045873
- Sponsor's protocol ID
- KY20192060-F-1
- Status last verified
- Jul 2019
- First submitted
- 4 Aug 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Clinical Trial of Hemodynamic Support With ECMO and IABP Versus IABP Alone, in Complex High-risk Patients Undergoing Elective PCI(PIONEER Trial)
- ClinicalTrials.gov ID
- NCT04045873
- Acronym / sponsor ID
- KY20192060-F-1
- Conditions
- Coronary Artery Disease, Heart Failure
- Keywords
- Complex high-risk patients, Percutaneous coronary intervention, Extracorporeal membrane oxygenation, Intra-aortic balloon pump
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Bethune International Peace Hospital, Beijing Anzhen Hospital, The Second Affiliated Hospital of Harbin Medical University, The General Hospital of Northern Theater Command
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 6 Aug 2019 (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.
To determine whether hemodynamic support combining VA-ECMO with IABP could mitigate the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs), compared with IABP support alone, in patients undergoing elective and high-risk PCI.
Detailed description
Percutaneous Coronary Intervention (PCI) supported by mechanical circulatory device may be a viable alternative for these patients with complex coronary artery disease combined with multiple comorbidities and poor hemodynamics. Extracorporeal Membrane Oxygenation (ECMO) can direct blood flow out of the body, oxygenate it, and then return it, to either completely or partially replace the function of the heart and lungs, and potentially increase the likelihood of functional recovery. Limitations of ECMO include lack of direct LV unloading, and increased LV afterload with subsequent LV overload, which in turn can increase myocardial oxygen demand and therefore limit any cardioprotective benefits . Measures to concurrently decrease LV afterload during ECMO, such as use of an Intra-Aortic Balloon Pump (IABP), may in theory offset some of the disadvantages of ECMO. To date, ECMO has most commonly been used in patients suffering from cardiac arrest and cardiogenic shock . As far as we are aware, there exist very limited reported data from monocentric observational studies and individual case reports on the use of ECMO for elective, high-risk PCI in the literature . More importantly, no previous randomized studies to evaluate the safety and efficacy of a strategy combining VA-ECMO and IABP during high-risk PCI have been conducted to date. Most importantly, the strategy of combined VA-ECMO and IABP has never been investigated in any randomized trial that we could find.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO plus IABP | Experimental | Device: extracorporeal membrane oxygenation |
| IABP | Experimental | Device: extracorporeal membrane oxygenation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged from 18 years to 85 years who meet any one of the following criteria
- Criteria Defining a Complex Procedure
- Bifurcation requiring PCI in two branches (including PTCA or stenting).
- Calcification requiring atherectomy.
- Tortuosity requiring device assistance.
Key exclusion criteria (12 listed)
- Acute myocardial infarction within the previous 48 hours.
- Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
- Cardiogenic shock.
- Complications of acute myocardial infarction (including ventricular septal defect, severe mitral regurgitation, and intractable ventricular arrhythmias).
- Contraindications to IABP or ECMO use, including significant iliac or femoral arterial disease and more than mild aortic regurgitation as seen on echocardiography.
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 |
|---|---|---|
| extracorporeal membrane oxygenationAlso: intra-aortic balloon pumpThe VA-ECMO procedure will be performed by femoral artery access, and the IABP will then be implanted in the contralateral femoral artery. | Device | ECMO plus IABP, IABP |
Primary outcome
The primary efficacy end point is the composite rate of MACCE at peri-procedure, in-hospital, or within a 30-day follow-up post-discharge.
Time frame: 30 days
The composite primary end point components include angiographic failure rates of PCI, all-cause death, myocardial infarction, stroke or transient ischemic attack, any repeat revascularization procedure, acute renal insufficiency, major vascular complications, severe intraprocedural hypotension requiring therapy, cardiopulmonary resuscitation, or ventricular tachycardia requiring cardioversion.
10 secondary outcomes
The rate of complete revascularization
Time frame: intra-procedure
intra-procedure hemodynamics
Time frame: intra-procedure
vascular access site and access-related complications
Time frame: intra-procedure
major or life-threatening or disabling bleeding
Time frame: 30 days
stroke or transient ischemic attack
Time frame: 30 days
acute kidney injury
Time frame: 30 days
MACCE at 6 months
Time frame: 6 months
MACCE at 1 year
Time frame: 1 year
MACCE at 2 years
Time frame: 2 years
MACCE at 3 years
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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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. This study is not recruiting at the moment.
Ling Tao, MD, PhD principal investigator
Xijing Hospital
Chunguang Qiu, MD, PhD study director
The First Affiliated Hospital of Zhengzhou University
Leisheng Ru, MD, PhD study director
Bethune International Peace Hospital
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal membrane oxygenation in people with Coronary Artery Disease and Heart Failure, run by Xijing Hospital.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Liu, MD, PhD (86-02984775183, liuyimeishan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy end point is the composite rate of MACCE at peri-procedure, in-hospital, or within a 30-day follow-up post-discharge. (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 6 Aug 2019.