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Clinical Trials at St. Mary

Non-Oncology Clinical Trials

 

(updated 10/3/13) 

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

SMMC 13-007: ABSORB Randomized Controlled Trial (RCT) to evaluate the safety and effectiveness of the Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) System.

SMMC 13-010:  SILVER – AMI

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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

SMMC 06-016: Closure of Patent Foramen Ovale with PFO ACCESS Registry

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)

SMMC 11-012: IONTM Paclitaxel-Eluting Coronary Stent System US Post-Approval Stent Study 

SMMC 11-026: ALERTS - AngeLmed for Early Recognition and Treatment of Stemi Study

SMMC 13-007: ABSORB Randomized Controlled Trial (RCT) to evaluate the safety and effectiveness of the Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) System.

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CARDIOTHORACIC / CRITICAL CARE

 

SMMC 13-014:  IP-0009-12 Bolton Medical, Inc Post-Approval Study of the Relay Thoracic Stent-Graft with Plus Delivery System in Patients with Thoracic Aortic Aneurysms and Penetrating Ulcers

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CRITICAL CARE

SMMC 13-014:  IP-0009-12 Bolton Medical, Inc Post-Approval Study of the Relay Thoracic Stent-Graft with Plus Delivery System in Patients with Thoracic Aortic Aneurysms and Penetrating Ulcers

SMMC 13-018:  EXPANDED ACCESS IND FECAL MICROBIAL TRANSPLANTATION

 

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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 12-001: ACROSTUDY - A Multicenter, Post-Marketing, Surveillance Study of Somavert Therapy in Patients with Acromegaly

SMMC 12-007: Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study

SMMC 13-011:  A Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects with Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment with an Inhibitor of the Renin-Angiotensin System

 

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EMERGENCY DEPARTMENT

  • Presently there are no protocols available at SMMC

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ELECTROPHYSIOLOGY

SMMC 11-026: ALERTS - AngeLmed for Early Recognition and Treatment of Stemi Study

SMMC 11-026: MRI Study: Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study:  ACCENT

SMMC 13-006: ENTOVIS: PRO-MRI STUDY BY BIOTRONIK

SMMC 13-001: CARTO 3 System and realtime intracardiac ultrasound for ablation of drug refractory recurrent symptomatic paroxysmal AF: acute procedural outcomes study.

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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

SMMC 06-016:  Closure of Patent Foramen Ovale with PFO ACCESS Registry

SMMC 07-001: OP-1 (HDE #H010002)

SMMC 11-021: CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System

SMMC 11-022: Wingspan Stent System with Gateway PTA Balloon Catheter

SMMC 11-023: Neuroform Microdelivery Stent System

SMMC 12-002: Onyx Liquid Embolic System (Onyx HD-500)

 

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OBESITY

SMMC 12-007: Pivotal Aspiration Therapy with Adjusted Lifestyle (PATHWAY) Study

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PEDIATRICS

Presently there are no protocols available at SMMC

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NEUROSURGICAL

Presently there are no protocols available at SMMC

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NEUROVASCULAR

SMMC 06-016:  Closure of Patent Foramen Ovale with PFO ACCESS Registry

  • Principal Investigator:  Rakesh Shah, MD

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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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RENAL DISEASE

SMMC 13-011:  A Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects with Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment with an Inhibitor of the Renin-Angiotensin System

 

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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 

SMMC 11-009:  BIOFLEX-I: The treatment of iliac and femoral atherosclerotic lesions using the self-expanding Astron and Astron Pulsar stents

 

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WOUND MANAGEMENT

 SMMC 13-008:  DSC 127-2012-02 : A Randomized, Double-Blind, Parallel-group, Vehicle and Standard of Care-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects with Diabetes Mellitus

 

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