Previous Clinical Trials

Cardiac:

A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention / TIMI-38; PI: Thomas Stuver, MD; Date: 2004

TAXUS V: De Novo Lesion: A Randomized, Double-blind Trial to Assess TAXUS™ Paclitaxel-Eluting Coronary Stents, Slow-Release Formulation, in the Treatment of De Novo Coronary Lesions
PI: James Doling, MD; Date: 2003

The Medtronic RESOLUTE US Clinical Trial: 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 2.25 mm to 4.2 mm; PI: Thomas Stuver, MD; Date: 2009

ENDEAVOR A registry of how patients did after receiving DES Endeavor US Retrospective Assessment of the Efficacy of the Endeavor DES; PI: Thomas Stuver, MD; Date: 2009

Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2): Vaccine for pre CABG patients (Merck vaccine)
PI: Ronald Kirshner, MD; Date: 2009

Mosaic ® ULTRA ™ Bioprosthesis Aortic Valve (Post market study of valve sizing)
PI: Ronald Kirshner, MD; Date: 2006

Red CABG: The effect of Acadesine on Clinically Significant Adverse Cardiovascular and Cerebrovascular Events In High-Risk Subjects Undergoing Coronary Artery Bypass Graft (CABG) Surgery Using Cardiopulmonary Bypass (Protocol No. P05633): RED-CABG Trial (Reduction in Cardiovascular Events by AcaDesine in Subjects Undergoing CABG); PI: Ronald Kirshner, MD

Regulate: A Randomized, Open-Label, Multi-Center, Active-Controlled, Parellel Group Study to Determine the Efficacy and Safety of the REG-1 Anti-Coagulation System Compared to Bivalirudin in Subjects Undergoing Percutaneous Coronary Intervention; PI: Thomas Stuver, MD; Date: 2014; https://clinicaltrials.gov/ct2/show/NCT01848106?term=REG-1+Anti-Coagulation+System+Compared+to+Bivalirudin&rank=1

Ingevity: Prospective, Non-Randomized Clinical Study to Establish the Safety, Performance and Effectiveness of the Ingevity Active and Passive Fixation Pace/Sense Leads; PI: Principal: Mark Hamer, MD; Date: 2014; https://clinicaltrials.gov/ct2/show/NCT01688843?term=Ingevity&rank=1

CAPTIVATE: CAPTure Information Via Automatic Threshold Evaluation; a Prospective, Non-Randomized, Multi-Center, IDE Clinical Study; PI Thomas Stuver, MD; Date: 2014; https://clinicaltrials.gov/ct2/show/NCT02097290?term=captivate&rank=1

Longitudinal Surveillance Study of the 4-SITE Lead/Header System: Evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for patients. PI: Mark Hamer, MD; Date: 2014; https://clinicaltrials.gov/ct2/show/NCT01596595?term=4-site+lead+header&rank=1

Gastrointestinal (GI):

Crohn’s Stem Cell Trial: A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA-001) for the Treatment of Adults with Moderate to Severe Crohn’s Disease; PI: Kevin Casey, MD; Date 2013; http://clinicaltrials.gov/ct2/show/NCT01155362?term=Celgene+PDA001-002&rank=1

Crohn’s Stem Cell Trial: A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease; PI: Kevin Casey, MD; Date 2014; http://clinicaltrials.gov/ct2/show/NCT01769755?term=Celgene+PDA001-CD-003&rank=1

A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects with Active Crohn’s Disease; Protocol Number: GED-0301-CD-001; Kevin Casey, MD; Date 2015 https://clinicaltrials.gov/ct2/show/NCT02367183?term=A+Randomized%2C+Double-blind%2C+Multicenter+Study+to+Explore+the+Effect+of+GED-0301+on+Endoscopic+and+Clinical+Outcomes+in+Subjects+with+Active+Crohn%E2%80%99s+Disease&rank=1

OSIRIS Protocol No. 603 A Phase III, multicenter, placebo-controlled, randomized, double-blind study to evaluate the safety and efficacy of PROCHYMAL™ (ex vivo cultured adult human mesenchymal stem cells) intravenous infusion for the induction of remission in subjects experiencing treatment-refractory moderate-to-severe Crohn’s disease; PI: Kevin Casey, MD; Date: 2007

Critical Care:

TOPAZ Clinical Protocol AST-113: A Sample Collection Study to Validate the Astute Medical NephroCheckÔ£™ Test in Critically Ill Subjects at Risk for Acute Kidney Injury; PI: James Szalados, MD; Date: 2012 https://clinicaltrials.gov/ct2/show/NCT01573962?term=Topaz+acute+kidney+injury&rank=1