Status:
UNKNOWN
PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
Bethune International Peace Hospital
Conditions:
Coronary Artery Disease
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
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 comorbidi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04045873
Start Date
December 1 2019
End Date
June 1 2024
Last Update
August 6 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.