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PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI

Primary Purpose

Coronary Artery Disease, Heart Failure

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

extracorporeal membrane oxygenation

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Complex high-risk patients, Percutaneous coronary intervention, Extracorporeal membrane oxygenation, Intra-aortic balloon pump

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ECMO plus IABP

IABP

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The rate of complete revascularization

intra-procedure hemodynamics

vascular access site and access-related complications

major or life-threatening or disabling bleeding

stroke or transient ischemic attack

acute kidney injury

MACCE at 6 months

MACCE at 1 year

MACCE at 2 years

MACCE at 3 years

Full Information

NCT ID

NCT04045873

First Posted

August 4, 2019

Last Updated

August 4, 2019

Sponsor

Xijing Hospital

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

1. Study Identification

Unique Protocol Identification Number

NCT04045873

Brief Title

PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2019 (Anticipated)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Heart Failure

Keywords

Complex high-risk patients, Percutaneous coronary intervention, Extracorporeal membrane oxygenation, Intra-aortic balloon pump

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ECMO plus IABP

Arm Type

Experimental

Arm Title

IABP

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

extracorporeal membrane oxygenation

Other Intervention Name(s)

intra-aortic balloon pump

Intervention Description

The VA-ECMO procedure will be performed by femoral artery access, and the IABP will then be implanted in the contralateral femoral artery.

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

The rate of complete revascularization

Time Frame

intra-procedure

Title

intra-procedure hemodynamics

Time Frame

intra-procedure

Title

vascular access site and access-related complications

Time Frame

intra-procedure

Title

major or life-threatening or disabling bleeding

Time Frame

30 days

Title

stroke or transient ischemic attack

Time Frame

30 days

Title

acute kidney injury

Time Frame

30 days

Title

MACCE at 6 months

Time Frame

6 months

Title

MACCE at 1 year

Time Frame

1 year

Title

MACCE at 2 years

Time Frame

2 years

Title

MACCE at 3 years

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Liu, MD, PhD

Phone

86-02984775183

liuyimeishan@hotmail.com

Overall Study Officials: