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

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.

Conditions

• Coronary Artery Disease
• Heart Failure

Interventions

DEVICE

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.

Sponsors & Collaborators

• Xijing Hospital

  lead OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Bethune International Peace Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The General Hospital of Northern Theater Command

  collaborator OTHER

Principal Investigators

• Ling Tao, MD, PhD · Xijing Hospital

• Chunguang Qiu, MD, PhD · The First Affiliated Hospital of Zhengzhou University

• Leisheng Ru, MD, PhD · Bethune International Peace Hospital

• Jinghua Liu, MD, PhD · Beijing Anzhen Hospital

• Bo Yu, MD, PhD · The Second Affiliated Hospital of Harbin Medical University

• Quanming Jing, MD, PhD · The General Hospital of Northern Theater Command

• Chengxiang Li, MD, PhD · Xijing Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-31

Primary Completion

2021-07-31

Completion

2024-06-30