NCT04045873

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-07-01
• Completion: 2024-06-01
• First posted: 2019-08-06
• Last updated: 2019-08-06