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The Magenta Elevate™ High-Risk PCI Pivotal Study (Elevate III)

Clinical Trial Details

The purpose of this study is to evaluate the safety and effectiveness of the Elevate System for patients needing non-emergent percutaneous coronary intervention (PCI).

The Elevate System is an investigational heart pump device, which means it has not been approved by the U.S. Food and Drug Administration (FDA). It is being compared with an already approved heart pump device called the Impella System. The Impella System is approved for patients having HR-PCI.

Participants will be randomized into one of two study groups. Randomization is like flipping a coin and there is an equal chance of being assigned to either group. Participants will not know what group they are assigned to.

Total participation in the study will last 90 days after the procedure. Participants will have two (2) follow-up telephone calls from the study staff to see how they are feeling.

Key Eligibility: 

1) Age 18 to 89 years
2) Non-emergent, percutaneous coronary intervention (PCI) is planned

Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Dolores T. Reynolds, RN, BSN
(212) 746-4617
dtr2001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2503028615

ClinicalTrials.gov:

NCT07001332

Sponsor:

DRD-0001723

Status

Open to Enrollment

Age Group

Adult

Sponsor