Absorb: A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions

Short Description: This study is comparing an investigational device called the Abbott Vascular Absorb Bioresorbable Vascular Scaffold System (Absorb BVS) to commercially approved Xience stents in treating narrowed coronary arteries. The Absorb BVS is a temporary device which functions like a drug-eluting stent, but is made out of a plastic scaffold (as opposed to metal). Over time, the scaffold will break down and be resorbed into the artery wall leaving behind no permanent implant. Absorb BVS is a combination of a scaffold, the drug everolimus, and a delivery system. The Absorb BVS and Xience stents all use the drug everolimus to prevent the heart artery from re-narrowing.

Principal Investigator: Jeffrey W. Moses, MD

Alerts: ALERTS (AngeLmed for Early Recognition and Treatment of STEMI) Study

Short Description: The Guardian System is an implantable device that detects changes in electrical properties (ST elevations) indicative of a heart attack before patients have symptoms in order to notify subjects to seek medical attention. For patients who undergo a heart attack, prompt treatment has been shown to significantly improve clinical outcomes. Heart attacks are caused by a blocked coronary artery and most of the irreversible damage to the heart occurs during the first two hours after coronary occlusion occurs. Therefore, early arrival at the hospital is critical to improve outcomes. Despite efforts to educate patients, many take a "wait and see" approach and as a result, most often don't arrive at the hospital until 2.5-3.0 hours after onset of symptoms. If patients would take action earlier, their lives may be saved and the damage to their hearts reduced.

Principal Investigator: Giora Weisz, MD

Excel: Left Main PCI compared to CABG using the XIENCE PRIME™ or XIENCE V® Everolimus Eluting Coronary Stent System

Short Description: This study is comparing left main coronary artery stenting verses surgery. The current standard of care for treatment of stenotic (narrowed) left main coronary arteries is coronary artery bypass grafting (CABG). CABG involves a surgical procedure which bypasses stenotic arteries by grafting vessels from elsewhere in the body. An alternative to CABG is percutaneous coronary intervention (PCI), commonly known as coronary angioplasty. This study consists of a 1:1 randomized study of 2600 subjects with unprotected left main coronary artery disease. Subjects will be assigned to (1) Percutaneous Coronary Intervention using the XIENCE PRIME or XIENCE V EECSS or (2) CABG. Clinical follow-up will occur through 5 years with an option for additional follow-up to 10 years. The study is investigating non-inferior or superior rates of the composite measure of all cause mortality, myocardial infarction or stroke at the anticipated median follow-up of three years.

Principal Investigator: Jeffrey W. Moses, MD

Color: Chemometric Observations of Lipid Core Containing Plaques of Interest in Native Coronary Arteries Registry

Short Description: The COLOR study is a natural history study that follows 2000 patoents with coronary artery disease that have been evaluated with the intracoronary intravascular ultrasound and LipiScan imaging. The Lipisan uses near-infrared spectroscopic technology to assess lipid containing plaques in the coronary blood vessels.

Principal Investigator: Giora Weisz, MD

GE Data Collection: Data Collection during Percutaneous Coronary Interventions for the Development of Future Angiographic Software Tools

Short Description: The purpose of this research study is to collect images obtained during Percutaneous Coronary Interventions. These images will support the development of new software tools intended to improve visualization of stents in the coronary arteries.

Principal Investigator: Jeffrey W. Moses, MD


OCT CAV: Optical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant

Short Description: Cardiac allograft vasculopathy (CAV) is a serious problem in some patients after heart transplant. We are using Optical Coherence Tomography (OCT) to try to better understand this condition.

Principal Investigator: Giora Weisz, MD

Tryton: Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries (TRYTON)

Short Description: This study evaluates the safety & effectiveness of a special dedicated stent for branching arteries - the Tryton Side Branch Stent.

Principal Investigator: Jeffrey W. Moses, MD




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