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

NCT04045873 | Unknown DMC

• 1 other identifier: KY20192060-F-1
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (10)

• The rate of complete revascularization

  intra-procedure

• intra-procedure hemodynamics

  intra-procedure

• vascular access site and access-related complications

  intra-procedure

• major or life-threatening or disabling bleeding

  30 days

• stroke or transient ischemic attack

  30 days

Study Arms (2)

ECMO plus IABP

EXPERIMENTAL

Device: extracorporeal membrane oxygenation

IABP

EXPERIMENTAL

Device: extracorporeal membrane oxygenation

Interventions

extracorporeal membrane oxygenation DEVICE

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

Also known as: intra-aortic balloon pump

ECMO plus IABP; IABP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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）.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Bethune International Peace Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The General Hospital of Northern Theater Command: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Interventions

Extracorporeal Membrane Oxygenation; Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Counterpulsation; Assisted Circulation

Study Officials

• Ling Tao, MD, PhD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

• Chengxiang Li, MD, PhD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Liu, MD, PhD

CONTACT

86-02984775183; liuyimeishan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 6, 2019
• Study Start: December 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: June 1, 2024
• Last Updated: August 6, 2019

Record last verified: 2019-07