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Cardiology Research

Study Title: ARTISAN: iCAST™ RX De Novo Stent Placement for the Treatment of Atherosclerotic Renal Artery Stenosis in Patients With Resistant Hypertension. (Identifier: NCT01673373)

Study Purpose:  The purpose of this trial is to test how well the iCAST™ RX Stent works in patients diagnosed with atherosclerotic renal artery stenosis and whether or not increased blood flow by the stent will help to control blood pressure.

Principal Investigator: Mark Burket, M.D.

Study Coordinator: Chris Eisenhauer, RN BSN, for more information, please contact 419.383.3853.


Study Title: BIOFLEX-I: The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents.(Identifier: NCT01319812)

Study Purpose: The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.

Principal Investigator: Mark Burket, M.D.

Study Coordinator: Chris Eisenhauer, RN BSN, for more information, please contact 419.383.3853.


Study Title: Zilver® PTX® V: Drug-Eluting Peripheral Stent Post-Approval Study. (Identifier: NCT01901289)

Study Purpose: The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

Principal Investigator: Mark Burket, M.D.

Study Coordinator: Stephanie Marts, RN, for more information, please contact 419.383.3853.


Study Title:  AMG 145: A Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of AMG 145 Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization. (Identifier: NCT01813422)

Study Purpose: This study will evaluate whether low-density lipoprotein (LDL-C) lowering with AMG 145 results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in subjects with coronary artery disease taking lipid lowering therapy

Principal Investigator: William Coyler, M.D.

Study Coordinator: Chris Eisenhauer, RN BSN, for more information, please contact 419.383.3853


Study Title: ST Monitoring to Detect ACS Events in ICD Patients Study, IDE Study (Identifier: NCT01424722)

Study Purpose: This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.

Principal Investigator: Jennifer Cummings, M.D.

Study Coordinator: Stephanie Marts, RN, for more information, please contact 419.383.3853.


Study Title: Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering From Acute Decompensated Heart Failure. (Identifier: NCT01661634)

Study Purpose: The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).

Principal Investigator: Samer Khouri, M.D.

Study Coordinator: Stephanie Marts, RN, for more information, please contact 419.383.3853.



Study Title: Lutonix® Drug coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis (SFA ISR). (Identifier: NCT02063672)

Study Purpose: To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).

Principal Investigator: Mark Burket, M.D.

Study Coordinator: Stephanie Marts, RN, for more information, please contact 419.383.3853.

Last Updated: 6/17/14