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(updated 11/8/12)
CARDIOLOGY
SMMC 10-008: TRANSLATE-ACS: Observational Study Description H7T-US-B007 The TRANSLATE-ACS Study: TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome
• Principal Investigator: Ronald Fields, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
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INTERVENTIONAL CARDIOLOGY
SMMC 07-001: TAXUS PERSEUS: A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions
• Principal Investigator: George Heyrich, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 06-016: Closure of Patent Foramen Ovale with PFO ACCESS Registry
• Principal Investigator: Rakesh Shah, MD
• Clinical Coordinator: Kim Devine, CRNP, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 08-018: XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
• Principal Investigator: George Heyrich, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-010: ORBIT II: Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)
• Principal Investigator: Rakesh Shah, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-011: OMEGA: To evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion 28 mm in length (by visual estimate) in a native coronary artery 2.25 mm to 4.50 mm in diameter (by visual estimate
• Principal Investigator: George Heyrich, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-012: IONTM Paclitaxel-Eluting Coronary Stent System US Post-Approval Stent Study
• Principal Investigator: George Heyrich, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-026: ALERTS - AngeLmed for Early Recognition and Treatment of Stemi Study
• Principal Investigator: Rakesh Shah, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
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ENDOCRINE / DIABETES MANAGEMENT
SMMC 10-008: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
• Principal Investigator: Horatio Hidalgo, MD
• Clinical Coordinator: Kathryn Kay
• For additional information, email kkay@stmaryhealthcare.org
SMMC 11-012: OTSUKA/HN REGISTRY- An observational prospective registry to identify demographic and clinical characteristics of patients hospitalized with euvolemic and hypervolemic hyponatremia and assess the comparative effectiveness of available treatments and the impact on resource utilization
• Principal Investigator: Rakesh Shah, MD
• Clinical Coordinator: Christine Armetta, MBA
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 12-001: ACROSTUDY - A Multicenter, Post-Marketing, Surveillance Study of Somavert Therapy in Patients with Acromegaly
• Principal Investigator: Alan Schorr, DO
• Clinical Coordinator: Jennifer Torres, RN, OCN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 12-007: Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study
• Principal Investigator: Alan Schorr, DO
• Clinical Coordinator: Miki Haas, RN, BS
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 12-011: ELIXA (Evaluation of LIXisenatide in Acute coronary syndrome) A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event
• Principal Investigator: Alan Schorr, DO
• Clinical Coordinator: Miki Haas, RN, BS
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 12-017: MK 3102-018 A randomized, double-blind, placebo-controlled, multicenter study to assess cardiovascular outcomes following treatment with MK-3102 in Subjects with Type 2 diabetes.
• Principal Investigator: Alan Schorr, DO
• Clinical Coordinator: Miki Haas, RN, BS
• For additional information, email researchinstitute@stmaryhealthcare.org
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ELECTROPHYSIOLOGY
SMMC 11-026: ALERTS - AngeLmed for Early Recognition and Treatment of Stemi Study
• Principal Investigator: Rakesh Shah, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-026: MRI Study: Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study: IMPACT
• Principal Investigator: Eran Zacks, MD
• Clinical Coordinator: Sandy Burdulis
• For additional information, email sburdulis@mercerbuckscardiology.com
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OBESITY
SMMC 12-007: Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study
• Principal Investigator: Alan Schorr, DO
• Clinical Coordinator: Miki Haas, RN, BS
• For additional information, email researchinstitute@stmaryhealthcare.org
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PULMONARY
SMMC 09-003: Long-term Oxygen Treatment Trial (LOTT)
• Principal Investigator: Howard Lee, MD
• Research Advisor: Mary Iannacone, DO
• For additional information, email ianaconemary@yahoo.com
SMMC 11-002: STATCOPE - Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations
• Principal Investigator: Howard Lee, MD
• Research Advisor: Mary Iannacone, DO
• For additional information, email ianaconemary@yahoo.com
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VASCULAR INTERVENTION
SMMC 06-014: SAPPHIRE WW - P06-3603: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy: Post Marketing Study
• Principal Investigator: David Drucker, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-009: BIOFLEX-I: The treatment of iliac and femoral atherosclerotic lesions using the self-expanding Astron and Astron Pulsar stents
• Principal Investigator: David Drucker, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-017: OSPREY: Occlusive/Stenotic Peripheral Artery Revascularization Study
• Principal Investigator: Rakesh Shah, MD
• Clinical Coordinator: Marci Campbell, RN, BSN, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
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HUMANITARIAN DEVICE EXEMPTIONS
SMMC 02-009: JOSTENT® Coronary Stent Graft and JOSTENT® GraftMaster for the treatment of free perforation, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter
• Principal Investigator: Ronald Fields, MD
• Research Advisor: Kim Devine, CRNP, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 07-001: OP-1 (HDE #H010002)
• Principal Investigator: Bradley Fink, MD
• Research Advisor: Kim Devine, CRNP, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-021: CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System
• Principal Investigator: Robert Rosenwasser, MD
• Research Advisor: Kim Devine, CRNP, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-022: Wingspan Stent System with Gateway PTA Balloon Catheter
• Principal Investigator: Robert Rosenwasser, MD
• Research Advisor: Kim Devine, CRNP, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 11-023: Neuroform Microdelivery Stent System
• Principal Investigator: Robert Rosenwasser, MD
• Research Advisor: Kim Devine, CRNP, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
SMMC 12-002: Onyx Liquid Embolic System (Onyx HD-500)
• Principal Investigator: Robert Rosenwasser, MD
• Research Advisor: Kim Devine, CRNP, CCRP
• For additional information, email researchinstitute@stmaryhealthcare.org
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