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Cardiology Research

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: 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

 


Study Title:  A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-M added-on to treprostinil, inhaled (Tyvaso®) in Subjects with Pulmonary Arterial Hypertension (BEAT) (Identifier: NCT01908600)

Study Purpose: Patients new to Tyvaso®, will enter a run-in period on inhaled treprostinil until 90 days of experience is achieved to ensure drug tolerability before enrolling in the study.

Principal Investigator: George Moukarbel, MD

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

 


Study Title: US-based, Observational, Drug Registry Opsumit® (macitentan) new users in clinical practice (OPUS) (Identifier: NCT02126943)

Study Purpose:  Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit® in the post-marketing setting

Principal Investigator: Samer Khouri, M.D.

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

 


Study Title:   A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients with Pulmonary Arterial Hypertension not on Active Treatment (MOTION)  (Identifier: NCT02191137)

Study Purpose:  The study is designed to further explore patient-reported outcomes in PAH subjects who are not on active treatment and living in the United States.  In addition the study will be exploring the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 minute walking distance in patients with PAH.

Principal Investigator:  Samer Khouri, M.D.

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

 

 


 

 

Last Updated: 8/21/15