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Search / Trial NCT07149714

Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI

Launched by ยท

Trial Information

Current as of September 09, 2025

Recruiting

Keywords

Mechanical Circulatory Support High Risk Percutaneous Coronary Intervention Coronary Artery Disease

ClinConnect Summary

This clinical trial is studying a new temporary heart support device called the iVAC 2L, which is used during a procedure called high-risk percutaneous coronary intervention (PCI). PCI is a treatment that opens blocked heart arteries but can be risky for some patients, especially those with serious heart artery disease or heart failure. The iVAC 2L device helps support the heart by assisting blood flow during the procedure, aiming to keep the heart stable and improve both short- and long-term outcomes.

People who may be eligible for this study are adults between 65 and 74 years old who have significant coronary artery disease and are scheduled for a high-risk PCI. If you join, the device will be temporarily placed through an artery in your leg and positioned in the heart to help pump blood during the procedure. The study will follow participants to see how safe the device is and whether it reduces serious problems like heart attack, stroke, or death during the hospital stay and up to one year afterward. This trial is currently recruiting patients and includes both men and women who meet the criteria.

Gender

ALL

Eligibility criteria

About

No description available.

Locations

Patients applied

0 patients applied

Trial Officials

Dmitry Pevzner, MD

Principal Investigator

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Evgeniy Merkulov, MD

Principal Investigator

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported