StudyFinder
THE MAGENTA ELEVATE HIGH-RISK PCI PIVOTAL TRIAL PROTOCOL (ELEVATE III)
Status: Recruiting
For patients having a procedure to open severe blockages in the heart's arteries. Due to your severe blockages and weakened heart function, you may be at higher risk of having a drop in blood flow. THE MAGENTA ELEVATE device heart pump device is used during the procedure. This device is intended to prevent drops in blood flow during the procedure. It does this by assisting the heart in pumping blood through the body.
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
Heart function less than 50%. Participant signed the informed consent. Additional criteria will be assessed prior to enrollment.
Exclusion Criteria:
You may not participate IF: 1. Age less than 18 and greater than 89 years old. 2. Cardiac arrest or Cardiogenic shock 3. Prior stroke or TIA within 3 months prior to enrollment. 4. Participant is presently or has recently been intubated. Additional criteria will be assessed prior to enrollment.Interventions:
Drug/Device: The Magenta Elevate? System
Conditions:
HIGH RISK PCI, CAD, CORONARY STENOSIS
Keywords:
CAD, CARDIAC CATHETERIZATION, CORONARY STENOSIS, PCI
Contact(s): MICHELLE BUTCHER - MBUTCHE1@HFHS.ORG
Principal Investigator: Mir Babar Basir
Principal Investigator ID: mbasir1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov