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

NCT ID: NCT04045873

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2024-06-30

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.

Conditions

Coronary Artery Disease; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECMO plus IABP

Group Type: EXPERIMENTAL

extracorporeal membrane oxygenation

Intervention Type: DEVICE

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

IABP

Group Type: EXPERIMENTAL

extracorporeal membrane oxygenation

Intervention Type: DEVICE

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

Interventions

extracorporeal membrane oxygenation

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

Intervention Type: DEVICE

Other Intervention Names

intra-aortic balloon pump

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Bethune International Peace Hospital

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

The General Hospital of Northern Theater Command

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Tao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Chunguang Qiu, MD, PhD

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Zhengzhou University

Leisheng Ru, MD, PhD

Role: STUDY_DIRECTOR

Bethune International Peace Hospital

Jinghua Liu, MD, PhD

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Bo Yu, MD, PhD

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Harbin Medical University

Quanming Jing, MD, PhD

Role: STUDY_DIRECTOR

The General Hospital of Northern Theater Command

Chengxiang Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Central Contacts

Yi Liu, MD, PhD

Role: CONTACT

liuyimeishan@hotmail.com

86-02984775183

Other Identifiers

KY20192060-F-1

Identifier Type: -

Identifier Source: org_study_id