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Interventional


RESPECT: The purpose of this study is to investigate whether percutaneous PFO (Patent Foramen Ovale) closure is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke or transient ischemic attacks.

IVUS: This protocol utilizes state-of-the-art flat dector technology, calibrated rotational acquisition, automated contrast injection, and novel image processing algorithms to investigate the feasibility of performing single-injection coronary angiography with subsequent completely automated coronary reconstruction including high-resolution 3-D images of coronary lesions per stent deployment and comparing it to IVUS interrogations which are considered standard of care.

Selective Chamber Angiography: This study is a development project for implementing a clinical imaging protocol involving a rotational X-ray acquisition of contrast filled cardiac chambers during a cardiac catheterization procedure. These 2-D rotational projection images will then be used to help develop, refine, and validate image processing techniques that will produce 3 and 4-D (3-D plus time) reconstructions of the cardiac chambers and implanted devices.

ACP: This study is a prospective, randomized, multicenter, active control to evaluate the safety and effectiveness of the ACP (Amplatzer Cardiac Plug) device in preventing thrombus from migrating from the left atrial appendage (LAA) in subjects who have non valvular atrial fibrillation, and is an alternative to long-term anticoagulation therapy. 

REALISM: This study is a prospective, multi-center, continued access registry of the Evalve Cardiovascular Repair System in the treatment of mitral valve regurgitation. The study will consist of two arms: high risk arm and a non-high risk arm. The study will provide valuable new information regarding the use of the MitraClip® System under more “real world” conditions and data regarding changes in functional capacity after successful MitraClip placement.

Resolute: This study is a clinical evaluation of the Medtronic Endeavor® Resolute Zotarolimus-Eluting Coronary stent system in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 3.8 mm. The will evaluate how safe and effective the drug-eluting study stent is in reducing narrowing in the coronary arteries over time.

Educate: The purpose of this study is to collect information about how two different time periods of anti platelet therapy (two blood thinning medicines taken by mouth in pill form to prevent blood clots) following a stent procedure keep patients free from death, heart attack, stroke, bleeding, or blood clots.

RABIT D: This project called RegAdenoson Blood flow in Type 1 Diabetes (RABITD) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age 20-55, minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is being followed for progression of coronary artery calcification (CAC) measured using the electron beam tomography (EBT) for development of clinical CVD. Participants have been well characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations 3 and 6 years later. The study has provided important insights into the risk factors and possible prevention of premature CVD in T1D. We are proposing assess a subset of this population to determine vasodilatory reserve as it relates to early coronary atherosclerosis in T1D. 

SAPPHIRE: This study is a multi-center, prospective, observational study to estimate 30-day MAE rate of stenting (any death, stroke or any MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid arteries.

CABANA: This study is a multi-center U.S. Surveillance Registry to compile early clinical outcomes using death, stroke, and myocardial infarction (MI) rate ≤30 days, in total and by center experience tier.