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

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

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

    1. Unprotected left main coronary artery disease with severe LV dysfunction (EF<35% or NYHA grade Ⅲ and Ⅳ).
    2. 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. 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

  1. Bifurcation requiring PCI in two branches (including PTCA or stenting).
  2. Calcification requiring atherectomy.
  3. Tortuosity requiring device assistance.
  4. Difficult CTO(J-CTO score≥2).

Exclusion Criteria:

  1. Acute myocardial infarction within the previous 48 hours.
  2. Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
  3. Cardiogenic shock.
  4. Complications of acute myocardial infarction (including ventricular septal defect, severe mitral regurgitation, and intractable ventricular arrhythmias).
  5. Contraindications to IABP or ECMO use, including significant iliac or femoral arterial disease and more than mild aortic regurgitation as seen on echocardiography.
  6. Bleeding diathesis or warfarin therapy with an international normalized ratio greater than 2.5.
  7. Active internal bleeding (including menstruation) within the past month.
  8. Recent ischemic stroke within the past month diagnosed by CT or MRI.
  9. Previous hemorrhagic stroke diagnosed by CT or MRI.
  10. Allergy to aspirin, clopidogrel, heparin, ticagrelor or glycoprotein IIb/ IIIa inhibitors; thrombocytopenia.
  11. Pregnancy.
  12. 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:
  • intra-aortic balloon pump
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:
  • intra-aortic balloon pump

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

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

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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