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Clinical Research

Current Clinical Trials at East Tennessee Heart Consultants

  • ACT I - A Prospective, Randomized, Parallel, Two-Arm, MultiCenter Trial. Carotid angioplasty and stenting versus endarectomy in asymptomatic subjects, who are at standard risk for carotid endarterectomy with significant extracranial carotid occlusive disease. The randomization employs a 3:1 ratio of CAS versus CEA.
     
  • Atrium iCast Iliac Stent Pivotal Study - A Prospective, Multicenter, Non-randomized, One Arm Registry to evaluate the iCast Covered Stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with a de nevo or restenotic lesions in the common and/or iliac arteries.
     
  • CHOICE - A Post-Market, Non-Randomized, Multi-Center Study of two carotid stent systems and two embolic protection systems. Carotid Stenting for high surgical risk patients evaluating outcomes through the collection of clinical evidence.
     
  • CREST - Carotid Revascularization Endarectomy vs Stenting Trials, Randomized Phase. Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and the University of Medicine and Dentistry of New Jersey.
     
  • DETECT Feasibility Study - A feasibility Study designed to investigate the safety of implanting the Guardian System in subjects with a high risk of recurrent myocardial infarction due to Acute Coronary Syndrome. The Guardian is designed to continuously monitor the electrogram signal and detect ST shifts that could be indicative of a blockage of a coronary artery.
      
  • EPIC - MultiCenter, Prospective, Pivotal Study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.
     
  • PFO Access Registry - Patient Foramen Ovvale Closure with Amplatzer PFO Occluder in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovvale who have failed conventional therapy.
     
  • PROTECT - Protected Carotid Artery Stenting in Subjects at high Risk for Carotid Endarectomy. A Prospective, Non-Randomized, Multicenter, Single Arm Trial. All Subjects will receive Xact Rapid Exchange carotid system; the first 220 patients will be treated with the investigational Emboshield, Pro-Rapid Exchange Embolic Protection System. The remaining subjects will be treated with the FDA approved Emboshield Embolic Protection System.
     
  • RELAX (REvascularization of Leg Arteries with the Xpert™ stent)
     
  • RIGHT - Rhythm ID Going Head to Head Trial - A Randomized Two Arm Trial that will investigate the differential detection and classification of arrhythmias by Guidant and Medtronic ICDS in patients receiving ICD Therapy.
     
  • ROCKET AFIB - A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) with Adjusted-Dose Oral Warfarin for the Prevention of Strokes and Non-Central Nervous System Systemic Embolism in Subjects with Non-Valvular Atrial Fibrillation Protocol 39039039AFL3001; Phase 3, (EudraCT number 2006-004595-13), BAY59-7939/11630, JNJ39039039 (rivaroxban, BAY 59-7939)
     
  • Sapphire WW - A Multi-Center, Prospective Observational Study; Stenting and Angioplasty with Protection in patients at high risk for endarectomy utilizing Cordis Precise Nitinol Stent System and Angioguard XP Emboli Capture Guidewire System.
     

 

 

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