NCT06373120: REC-CHIPMCS

Interventional Ventricular Assist System for PCI in CHIP Patients

Active, enrolled NA Last updated 12 January 2026

What this trial tests

NA trial testing Microaxial flow pump in High-Risk Percutaneous Coronary Intervention (High-risk PCI) in 262 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 March 2024

Primary endpoint
13 February 2025

13 February 2026

Quick facts

Lead sponsor	Shenzhen Core Medical Technology CO.,LTD.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	262
Start date	4 March 2024
Primary completion	13 February 2025
Estimated completion	13 February 2026
Sites	1 location across China

Drugs / interventions tested

• Microaxial flow pump
• VA-ECMO

Conditions studied

• High-Risk Percutaneous Coronary Intervention (High-risk PCI) — all drugs for High-Risk Percutaneous Coronary Intervention (High-risk PCI) →
• Left Ventricular Assist Devices — all drugs for Left Ventricular Assist Devices →

Sponsor

Shenzhen Core Medical Technology CO.,LTD.

Who can join

Adults 18 to 90, any sex, with High-Risk Percutaneous Coronary Intervention (High-risk PCI) or Left Ventricular Assist Devices. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).

During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.

There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.

The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Extracorporeal Membrane Oxygenation to Support the Circulation in Interventional Cardiac Procedures.
   Brewer JM, Maybauer MO. · · 2024 · PMID 38963352 · DOI 10.4103/aca.aca_122_24