Trials: Heart & Vascular

ACUITY (closed - results published)

This trial’s results were published in the New England Journal of Medicine in November 2006. It explored the potential of the injectable anti-clotting medicine Angiomax® (bivalirudin) in patients experiencing ACS. The results showed that Angiomax, in the “Angiomax alone” treatment group, was effective and reduced the risk of major bleeding—a key risk factor for mortality—by 47 percent compared to the standard combination of injectable drugs.

APPRAISE 2 (closed - results published)

The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome.

CHAMPION Phoenix (active - not recruiting)

The study is designed to compare the efficacy and safety profile of cangelor to standard of care in patients that require percutaneous coronary intervention (PCI).

DAPT (active - not recruiting)

To assess the effectiveness and sefety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing Percutaneous coronary intervention.    

DETERMINE (closed)

To determine if Implantable Cardioverter Defibrillator therapy in combination with medical therapy in patients with an infarct size greater than or equal to 10 percent of the left ventricular mass improves long term survival compared to medical therapy alone.  

IMPROVE-IT (closed)

To evaluate the clinical benefit of Vytorin compared with Simvastatin in stabilized acute coronary syndrome subjects (ACS) --either acute myocardial infarction or unstable angina.

OptiVol Care Pathway (closed)

To compare monthly versus quarterly review of CardiacCompass Trends with OptiVol for initiation of clinical action.    

OSPREY (currently recruiting)

OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. The study objectives are to demonstrate that efficacy and safety of this novel stent design are not inferior to historical PtA and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al.

PROVIDE (closed)

The objective of the post-marketing surveillance study id to collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics will be able to (1) Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface information and overall customer satisfaction, and (3) Monitor post-marketing device performance and safety for quality adherence.

QuickFlex (currently recruiting)

The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ Model 1258T  left ventricular lead.

RESPECT (currently recruiting)

To evaluate the safety and efficacy of the Rapid Extravascular Sealing via PercutanEous Collagen ImplanT    

SATURN (Closed)

This trial will study patients who have a clinical indication for a coronary catheterization and who have coronary artery disease.  It will evaluate whether two cholesterol medications differ in their effects on coronary artery atheroma burden, as measured by intravascular ultrasound imaging.  The study will also assess whether or not either drug is associated with regression of atheroma volume.

SCORE Registry

The primary purpose of this registry is to track problems with and long-term performance of St. Jude Medical continuous rhythm devices.

TAXUS Liberte` (currently recruiting)

The TAXUS Liberte` Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberte`Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This study is designed to evaluate the optimal duration of dual antiplatelet therapy.