- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04045873
PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI
August 4, 2019 updated by: Xijing Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
306
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Liu, MD, PhD
- Phone Number: 86-02984775183
- Email: liuyimeishan@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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).
- Calcification requiring atherectomy.
- Tortuosity requiring device assistance.
- Difficult CTO(J-CTO score≥2).
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ECMO plus IABP
|
The VA-ECMO procedure will be performed by femoral artery access, and the IABP will then be implanted in the contralateral femoral artery.
Other Names:
|
EXPERIMENTAL: IABP
|
The VA-ECMO procedure will be performed by femoral artery access, and the IABP will then be implanted in the contralateral femoral artery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of complete revascularization
Time Frame: intra-procedure
|
intra-procedure
|
intra-procedure hemodynamics
Time Frame: intra-procedure
|
intra-procedure
|
vascular access site and access-related complications
Time Frame: intra-procedure
|
intra-procedure
|
major or life-threatening or disabling bleeding
Time Frame: 30 days
|
30 days
|
stroke or transient ischemic attack
Time Frame: 30 days
|
30 days
|
acute kidney injury
Time Frame: 30 days
|
30 days
|
MACCE at 6 months
Time Frame: 6 months
|
6 months
|
MACCE at 1 year
Time Frame: 1 year
|
1 year
|
MACCE at 2 years
Time Frame: 2 years
|
2 years
|
MACCE at 3 years
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Chunguang Qiu, MD, PhD, The first affiliated hospital of Zhengzhou University
- Study Director: Leisheng Ru, MD, PhD, Bethune International Peace Hospital
- Study Director: Jinghua Liu, MD, PhD, Beijing Anzhen Hospital
- Study Director: Bo Yu, MD, PhD, The Second Affiliated Hospital of Harbin Medical University
- Study Director: Quanming Jing, MD, PhD, The General Hospital of Northern Theater Command
- Principal Investigator: Chengxiang Li, MD, PhD, Xijing Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2019
Primary Completion (ANTICIPATED)
July 1, 2021
Study Completion (ANTICIPATED)
June 1, 2024
Study Registration Dates
First Submitted
August 4, 2019
First Submitted That Met QC Criteria
August 4, 2019
First Posted (ACTUAL)
August 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 6, 2019
Last Update Submitted That Met QC Criteria
August 4, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20192060-F-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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