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

Master II: MGuard™ Prime Stent System Clinical Trial in Patients with Acute ST Elevation Myocardial Infarction

Short Description:This study is designed as a prospective, multicenter, single-blinded randomized controlled trial to assess the effectiveness and safety of MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary PCI due to acute STEMI as compared with FDA-approved BMS or DES (control stent selected at the discretion of the investigator).
Acute Myocardial Infarction (AMI), usually the consequence of a sudden blockage of a major artery in the heart, can lead to a number of negative outcomes, including heart failure and death. In the event of an AMI, patients undergo a cardiac catheterization to receive a stent as quickly as possible in order to minimize the damage done to the heart.
During the stent procedure, some material from the blockage may break off and cause some additional damage to the heart. The MGuard Prime bare metal stent is covered with a fiber mesh that is designed to trap that material and minimize this additional damage.
Stent implantation will be performed with the MGuard™ Prime System in the treatment group or a control stent in the control group, randomized in a 1:1 ratio. Enrollment will include 1114 subjects at up to 70 sites worldwide. Randomization will be stratified by LAD vs. non-LAD infarct vessel, by intent to use DES vs. BMS in the control arm (declared prior to randomization), and by site. Subjects will be followed for 13 months.
Please contact Kate Dalton, MS, RD, CCRC at if you have questions or would like to refer a patient.

Principal Investigator: LeRoy Rabbani, MD, National PI Gregg Stone, MD

OPEN CTO: Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion

Short Description: Historically, patients with Chronic Total Occlusion (CTO) were treated either with medical therapy alone or Coronary Artery Bypass Graft surgery (CABG), due to the complex nature of the lesion. The lesions are technically difficult to treat by Percutaneous Coronary Intervention (PCI) relative to non-chronically occluded vessels. Recent developments in PCI techniques and technologies have allowed skilled operators to achieve higher success and safety rates. These new developments include the Hybrid CTO Approach, which is a combination of conventional antegrade wiring combined with dissection-reentry and retrograde techniques to treat a CTO percutaneously. The aim of this study is to use this systematic approach to address current gaps in knowledge. Please contact Kate Dalton, MS, RD, CCRC at if you have questions or would like to refer a patient.

Principal Investigator: Jeffrey W. Moses, MD

LRP: Lipid Rich Plaque

Short Description: This is a multicenter, prospective registry of 9,000 subjects with stable ischemic heart disease or a stabilized acute coronary syndrome (ACS) examined with angiography and IVUS-NIRS imaging for one or more suspected culprit lesions. After successful PCI of all angiographically flow-limiting lesions, intravascular imaging with the combined IVUS-NIRS catheter will be performed in all three coronary arteries if possible. Successful imaging of at least two vessels and a total of 50 mm of coronary artery is required for enrollment. All enrolled patients with a large LRP as detected by NIRS will be contacted at 2,6,12 and 24 months by phone to determine if a new coronary event has occurred. A randomly selected half of the patients with a small, or no, LRP will receive an identical follow-up. The origin of any new event will be determined by the follow-up angiography performed for clinical indications. The location of new culprit lesions will be identified and compared to the baseline NIRS findings in a central angiographic and NIRS-IVUS core laboratory located at MedStar.
Patients with stable ischemic heart disease or an ACS and planned coronary angiography in whom IVUS-NIRS imaging is planned will be asked to participate. Angiography and PCI will be performed as clinically indicated. Unblinded NIRS IVUS imaging will be performed in the vessel, or vessels, containing a single or multiple suspected culprit lesions. Imaging for research purposes will begin in non-culprit vessels after all clinically indicated PCI has been performed. The goal is to image all 3 vessels. Please contact Kate Dalton, MS, RD, CCRC at if you have questions or would like to refer a patient.

Principal Investigator: Ziad Ali, MD

COAST: Coronary Orbital Atherectomy System Study

Short Description: Coronary artery disease (CAD) affects over 16 million subjects in the US, making it the most common form of heart disease. Despite advances in interventional equipment and techniques, there are patient populations who remain challenging to treat, including patients with calcified lesions. increased calcium deposits lead to a higher incidence of major adverse cardiac events (MACE), in particular the rate of non-Q wave myocardial infarction, when compared to non-calcified lesions. In addition, as the concentration of lesion calcification increases it has been shown to be associated with vessel dissection during PCI, failure to deliver a stent, balloon ruptures and un-dilatable lesions. Adequate plaque modification may improve both acute &long term outcomes in subjects with heavily calcified lesions undergoing Percutaneous Coronary Intervention (PCI). Cardiovascular Systems Inc. (CSI) has developed the Diamondback 360® Coronary Micro Crown Orbital Atherectomy System (micro crown OAS) which is considered an investigational device. The OAS utilizes a diamond-coated eccentric crown that, while rotating over an atherectomy guide wire, expands the lumen diameter laterally via centrifugal forces. The purpose of the study is to demonstrate the safety and efficacy of the micro crown OAS in treating de novo, severely calcified coronary lesions in adult subjects. Please contact Kate Dalton, MS, RD, CCRC at if you have questions or would like to refer a patient.

Principal Investigator: Jeffrey W. Moses, 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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