Clinical Research Unit
Clinical Trials and Registries

CORONARY ARTERY DISEASE

CURRENT
Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy

Principal Investigator
Anilkumar Mehra, M.D.

Study Coordinator
Cesar Ochoa

Purpose
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin will decrease the risk of ischemic complications, defined as cardiac death, stroke, myocardial infarction, after a percutaneous coronary intervention (PCI) in patients with Acute Coronary Syndrome (ACS) . Clopidogrel is approved by the FDA. However, the use of clopidogrel in this study is considered experimental because the FDA has not approved clopidogrel in the doses that will be used in this study.

Enrollment Status: OPEN

PROTECT II
A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to evaluate the safety and performance of the IMPELLA RECOVER LP 2.5 System for use during the treatment of coronary artery interventions. Patients enrolled in this study will be randomized to receive either the IMPELLA device or an intra-aortic balloon pump (IABP).

The IMPELLA RECOVER LP 2.5 System is a device recently cleared by the FDA for commercial use in the United States, for use in patients who need help pumping blood from the heart to the rest of the body for up to 6 hours. The System, when used in the study, can be used for a longer period of time. The system works by placing a small pump into the left pumping chamber of the heart to circulate blood throughout the body.

Enrollment Status: OPEN

XIENCE
XIENCE V Everolimus Eluting Coronary Artery Stenting System (EECSS) USA Post-Approval Study

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to evaluate the continued safety and effectiveness of the XIENCET V Everolimus Eluting Coronary Stent System(XIENCE V EECSS). The XIENCET V Everolimus Eluting Coronary Stent System is approved for use by the FDA for the treatment of patients with narrowed coronary arteries.

Enrollment Status: PENDING