6 studies found

The Medtronic CoreValve Evolut R US Clinical Study

Transcatheter aortic valve implantation (TAVI) has become a routine treatment option at specialized heart centers treating patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement (SAVR). Medtronic has developed modifications to the Medtronic CoreValve System Transcatheter Aortic Valve frame and delivery catheter system to...

COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils

1.0 INTRODUCTION 1.1 Background Intracranial aneurysms (IAs) are common cerebrovascular abnormalities. The prevalence of IAs has been reported to be 0.8-2.0% of the population. [1-3] The most common presentation of IAs is subarachnoid hemorrhage (SAH), the annual incidence of which varies by geographic region from 10 to 20 per 100,000....

AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will...

Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links with Clinical Outcomes

Observational study to collect F/U imaging & clinical endpoint data from pts. who successfully completed baseline coronary IVUS (intravascular ultrasound) imaging in the dal-PLAQUE 2 (DP2) study to determine the correlation & clinical relevance of such imaging as related to coronary artery disease (CAD). Pts. who have had baseline angiography/IVUS,...

Medtronic CoreValve® U.S. Expanded Use Study

The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a composite of all-cause death or major...

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries. The purpose of this trial is...