View Information for Trials
Trial Name Sponsor Principal Investigator Description Coordinator
EVOLVE Boston Scientific Erick A. Eways, MD, FACC A prospective, multicenter, single-arm study designed to assess the safety of 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System.  Enrolling. Ruth Wagner, RN, CRC
Impella RP  Abiomed Wail M. Hashimi, MD, FACC Sub Investigators:  Dr. John M. Galla and Dr. Kellan E. Ashley, MD. HDE for Abiomed Right Heart Impella.  Enrolling.
 Ruth Wagner, RN, CRC
Gore ISR Study  W.L. Gore Frank T. Bunch, MD, FACC, FSCAI  To evaluate post-market safety and effectiveness of Gore Viabahn for treatment of in-stent restenosis.  Enrolling. Mary Austin, RN, CCRC
MIMICS-2 Study  Veryan Medical Frank T. Bunch, MD, FACC, FSCAI
To demonstrate that the Biomimics stent meets the goal performance defined by VIVA Physicians Inc. for safety and effectiveness of Nitinol stents used to treat symptomatic disease in the SFA.  Enrolling. Mary Austin, RN, CCRC
ARTEMIS  AstraZenica Jason H. Cole, MD, MSc, FACC Sub Investigators: Dr. M. Wail Hashimi, Dr. Kellan E. Ashley and Robin Bates, PA-C.  The purpose of this study is to determine how long STEMI and NSTEMI take antiplatelet medication and hospital discharge, and how this influences patients long-term health and use of healthcare resources.  Closed to Enrollment. Ruth Wagner, RN, CRC
CONSERVE  MDDx Jason H. Cole, MD, MSc, FACC
 To determine the effectiveness, safety and cost efficiency associated with a CCTA - guided selective catheterization strategy for stable patients but with known CAD and an American Heart Association/American College of Cardiology Class II indication for non-emergent invasive coronary angiography.  Closed to Enrollment. Ruth Wagner, RN, CRC
The COPPER Trial-B Trial Horizons International Peripheral Group, LLC Frank T. Bunch, MD, FACC, FSCAI
The purpose of the COPPER-B trial is to asses the feasibility, safety, and initial efficacy of paclitaxel administration using the OPC for the prevention of restenosis in infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, the OPC.  Enrolling. Mary Austin, RN, CCRC
CREDENCE
NIH
Jason H. Cole, MD, MSc, FACC
Sub Investigators: Dr. M. Wail Hashimi and Dr. Kellan E. Ashley
Study seeking to determine the accuracy of using anatomic and physiological information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve.  The hypothesis of this proposal is that integrating anatomic plaque features with physiologic fraction flow reserve-CT will optimize identification of coronary lesions that are ischemia-causing by computed tomography.Enrolling.
Ruth Wagner, RN, CRC
Heart Failure Study  Janssen Kenneth M. Burnham, MD, FACC  Hearth Research Associates is conducting a cross-sectional quantitative pilot study using a web-based survey data entry platform to collect data from respondents with diagnosis of Chronic Heart Failure.  This study is non-interventional and aims to evaluate a newly-developed PRO instrument designed to assess symptoms and impact frequency and serverity in chronic heart failure.  Completed. Ruth Wagner, RN, CRC
 Lutonix ISR  Bard/Lutonix Frank T. Bunch, MD, FACC, FSCAI  A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix (R) Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis.  The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and occlusion or > 50% stenosis of a previously deployed bare nitinol stent(s) in the femoropopliteal artery that is appropriate for angioplasty.  After successful protocol-defined pre-dilatation, subjects are randomized 2:1 to treatment with either the LUTONIX(R) Drug Coated Balloon (test arm) or standard Percutaneous Transluminal Angioplasty (PTA) Catheter (control arm).  The primary safety and efficacy endpoint assessments are 12 months.  Clinical follow-up continues through 2 years and telephone follow-up through 5 years.  Enrolling. Mary Austin, RN, CCRC
ST JUDE SDD for ICD St. Jude Medical
D. Scott Kirby, MD, FACC Safety and cost effectiveness of Same day Discharge after implantable Cardioverter  Defibrillator implant verses Next day Discharge. Closed to Enrollment. Ruth Wagner, RN, CRC
TURBULENCE AUM Cardiovascular  Jason H. Cole, MD, MSc, FACC Clinical Evaluation of the CADence Device in Detection of Coronary Artery Disease.  This is a multi-center, prospective, non-randomized, double-blinded, trial to evaluate the performance of the CADence in detecting the existence of at least one major coronary artery with clinically significant stenosis in a subject. Completed.  Ruth Wagner, RN, CRC
 Ranolazine (Ranexa) for Diabetic Peripheral Neuropathy Pain Horizons International Peripheral Group, LLC Frank T. Bunch, MD, FACC, FSCAI RANOLAZINE FOR DPNP - A Phase 4, Double-blind, Placebo-Controlled, Randomized, Parallel U.S. Study of Ranolazine for the Treatment of Patients with Diabetic Peripheral Neuropathic Pain (DPNP).  The study objective is to determine if subjects suffering from diabetic peripheral neuropathic pain treated with Ranolazine will have greater reduction in pain compared to placebo.  The study will consist of a total of six (6) clinic visits at Cardiology Associates over a 10-12 week period.  Enrolling. Mary Austin, RN, CCRC
RIVAROX HFA 3001  Janssen
Kenneth M. Burnham, MD, FACC
Sub Investigators: Dr. Jason Cole & Stephanie Cleveland, PA
A randomized, double-blind, event-driven multicenter study comparing the efficacy and safety of oral Rivaroxaban with a placebo for reducing the risk of death, myocardial infarction or stroke in subjects with chronic heart failure and significant coronary artery disease following a hospitalization for exacerbation of heart failure.  Enrolling. 
Ruth Wagner, RN, CRC
ATMOSPHERE  Novartis Kenneth M. Burnham, MD, FACC A trial to study the efficacy and safety of both Tekturna® alone and Tekturna® /enalapril combination therapy with enalapril only in patients with chronic heart failure. Completed.
Ruth Wagner, RN, CRC
 EXCITE Trial Spectranetics Corporation Frank T. Bunch, MD, FACC, FSCAI
The EXCITE ISR trial is a prospective randomized controlled trial evaluating the safety and efficacy of Excimer Laser Atherectomy (ELA) using the Spectranetics Turbo Elite Laser Ablation Catheter and the Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter with adjunctive percutaneous transluminal angioplasty (PTA) to PTA alone in the treatment of femoropopliteal bare nitinol in-stent restenosis (ISR).  The objective of the EXCITE ISR trail is to gather data regarding the safety and effectiveness of performing ELA with PTA for the treatment of in-stent restenosis, at the time of procedure, and at follow-ups at 30 days, six (6) months, and 12 months after the procedure.  These results will be compared to treatment with PTA alone.  Closed to Enrollment.  Mary Austin, RN, CCRC
CHAMPION/ Investigational Device Study CardioMEMS John M. Galla, MD, FACC, FSCAI & Kenneth M. Burnham, MD, FACC Sub Investigators: Dr. J. Andrew Morrow & Dr. Richard J. Chernick
CardioMEMS Heart Sensor allows Monitoring of Pressure to Improve Outcomes in NYHA Class III heart failure. A Prospective, Multi-Center, Randomized, Single-Blind Clinical Trail designed to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subject suffering of heart failure. Completed.
Cheryl B. Flock, RN & Ruth Wagner, RN, CRC
IMPROVE-IT Schering – Plough Research Richard Chernick, MD, FACC Sub Investigators: Dr. J. Andrew Morrow
Multicenter, Randomized, Double-blind Study to Establish the Clinical Benefit and Safety of Vytorin VS Simvastatin Monotherapy in High Risk Subjects Presenting With Acute Coronary Syndrome. The primary objective of this study is to evaluate the clinical benefit of Vytorin/Simvastatin combination compared with Simvastatin treatment on Cardiovascular Death, Major Coronary Events, and Stroke. Closed to Enrollment.
Cheryl B. Flock, RN
LMI-BMS747158-301 Lantheus Jason H. Cole, MD, MSc, FACC A phase III, open-label, multi-center study for the medical assessment of myocardial perfusion using Positron Imaging Emission Tomography (PET) imaging of flurpiridaz F 18 injection in patients with known or suspected CAD. The primary objective of the study is to assess the diagnostic efficacy (sensitivity and specificity) of flurpiridaz F 18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant CAD as defined by invasive coronary angiography (ICA) or a documented history of myocardial infarction. Completed. Ruth Wagner, RN, CRC
PROMISE NHLBI
Jason H. Cole, MD, MSc, FACC
This trial is a multi-center, randomized, pragmatic trial comparing 2 state-of-the art diagnostic strategies in approximately 10,000 symptomatic, low-to- intermediate risk subjects with suspected CAD who require non-urgent testing. The “anatomic” testing strategy used will be coronary angiographic tomography. The “functional” testing strategy to be used will either be stress imaging (ECHO or nuclear) or exercise ECG as the initial test. Completed. Ruth Wagner, RN, CRC
PROMUS ElementTM Plus Boston Scientific Corporation Dr. Arthur G. Grant, III Sub Investigators: Dr. John M. Galla & Dr. M. Wail Hashimi. 
A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States. Closed to Enrollment.
Ruth Wagner, RN, CRC
RED - HF Amgen Richard Chernick, MD, FACC & Kenneth M. Burnham, MD, FACC Sub Investigators: Dr. J. Andrew Morrow
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure (HF) subjects with symptomatic Left Ventricular Systolic Dysfunction and Anemia. The primary objective of this study is to determine the efficacy of darbepoetin alfa compared with placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in subjects with symptomatic left ventricular systolic dysfunction and anemia. Completed.
Cheryl B. Flock, RN & Ruth Wagner, RN, CRC 
RESCUE ACRIN Jason H. Cole, MD, MSc, FACC This is a randomized, controlled, diagnostic, multi-center trial to evaluate patients with stable angina comparing utilization of diagnostic examinations (nuclear SPECT, CCTA, CATH). The primary objective of the study is to compare outcomes of participants with symptoms of stable angina or angina equivalent. Evaluated with an anatomic imaging strategy using CCTA as the initial method CAD diagnosis (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to optimal medical treatment.  Completed. Ruth Wagner, RN, CRC
SUPERB IDEV Technologies, Inc. Frank T. Bunch, MD, FACC, FSCAI Sub Investigator: Dr. J. McLean Trotter.
A prospective, multicenter, non-randomized, single arm trial. The primary objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA Nitinol Stent System in treating subjects with obstructive superficial femoral artery disease.  Completed.
Mary Austin, RN, CCRC
 TIGRIS  W. L. Gore Frank T. Bunch, MD, FACC, FSCAI The purpose of this study is to determine the safety and effectiveness of the GORE TIGRIS Vascular Stent (called the "study stent"), compared to BARD LifeStent (called the "control stent").  The control stent is the only stent approved by the Food and Drug Administration (FDA) for treating patients with obstructive peripheral artery disease (PAD), while the study stent is still in research studies in the US.  The study stent has been approved for use elsewhere in the world.  In this study, patients will be randomized in a 3:1 design to placement of either Tigris or LifeStent.  Closed to Enrollment. Mary Austin, RN, CCRC
The Jetstream G2 System Post-Market Peripheral Vascular Pathway Medical Technologies Frank T. Bunch, MD, FACC, FSCAI A prospective single-arm study. The purpose of this study is to assess and quantify the debulking capability of the Jetstream G2 System in peripheral artery disease interventions using the intravascular Ultrasound (IVUS) and to establish IVUS profiles and evaluate pre and post Jetstream G2 System luminal area, lesion volume, and morphology.  Closed to Enrollment. Mary Austin, RN, CCRC
Visipaque Registry GE Healthcare Jason H. Cole, MD, MSc, FACC Registry trial for patients undergoing Visipaque-enhanced CCTA as part of their routine medical care. Completed. Ruth Wagner, RN, CRC
CANOPY Trial Abbott Vascular  Frank T. Bunch, MD, FACC, FSCAI CANOPY is a prospective, multi-center, non-randomized, single arm, post-approval clinical trail.  The purpose of the CANOPY trial is to evaluate the safety and effectiveness of the RX Acculink Carotid Stent System, manufactured by Abbot Vascular, in subjects at standard risk for adverse events from carotid endarterectomy (CEA) who require carotid revascularization.  The objective of the CANOPY trail is to assess the performance outcome (death & stroke rate) of the RX Acculink Carotid Stent System under commercial use by collecting peri-procedural, (30 day) and long term post-approval data in patients at standard risk for adverse events from CEACompleted. Mary Austin, RN, CCRC
 OSPREY Trial Terumo Medical  Frank T. Bunch, MD, FACC, FSCAI  Sub Investigators:  Dr. Brian D. Dearing, Dr. McLean Trotter. 
The OSPREY trail is a multi-center, single arm, non-randomized, prospective clinical trial of the Misago self expanding stent for the treatment of atherosclerotic stenosis and occlusions of the superficial femoral artery (SFA).  The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days, 6, 12, 24 and 36 months post procedure.  The study objectives are to demonstrate that the efficacy and safety of this novel stent design are not inferior to historical percutaneous transluminal angioplasty (PTA) and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al..  Completed.
Mary Austin, RN, CCRC
 ASCEND HF  Scios Charles W. Parrott, MD, FACC, FSCAI & Kenneth M. Burnham, MD, FACC Sub Investigators: Dr. J. Andrew Morrow & Dr. Richard J. Chernick
Infusions of Natrecor® for the Management of Patients Hospitalized with Acute Decompensated Heart Failure. The primary objective of this study is to evaluate whether treatment with nesiritide improves patients outcomes (as measured by reduction in HF re-hospitalizations and all-cause mortality through 30 days after randomization).  Completed.

 ATOMIC-AHF  AMGEN John A. Morrow, MD, FACC, FACP Sub Investigators: Richard J Chernick MD and John M Galla MD A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure.  Completed.  
CHAMPION PHOENIX The Medicines Company
John M. Galla, MD, FACC, FSCAI   Sub Investigators: John A. Morrow, MD and Kenneth Francez, MD. A clinical trial comparing cangrelor to clopidogrel standard of care therapy in subjects who require percutaneous coronary intervention. Completed.  
 CHOICE  Abbott Vascular Frank T. Bunch, MD, FACC, FSCAI  Sub Investigator: Dr. Arthur G. Grant III.
A prospective, non-randomized, multi-center, descriptive, post-market study of two carotid artery stent systems and two embolic protection systems. The primary objectives of this study are to provide additional information that these commercially available products can be used successfully by a wide range of physicians under commercial use conditions, and to provide ongoing post-market surveillance for documentation of clinical outcomes. Completed
Mary Austin, RN, CCRC
 DeFACTO   Jason H. Cole, MD, MSc, FACC Determine the diagnostic performance of coronary computed tomographic angiography (CCTA) plus cFFR for non-invasive assessment of the hemodynamic significance of coronary artery disease (CAD), as compared to direct measurement of FFR during cardiac catheterization as a reference standard. Completed.  Ruth Wagner, RN, CRC
EASE Trial AtheroMed, Inc  Frank T. Bunch, MD, FACC, FSCAI The EASE trial is a prospective, multi-center clinical evaluation of the safety and effectiveness of the Phoenix Atherectomy System for the treatment of de novo and restonic atherosclerotic lesions located in the superficial femoral artery (SFA), popliteal or infrapopliteal native vessels.  The primary objective of this study is to estimate freedom from Major Adverse Events (MAE's) evaluated immediately post procedure through 30 days and 6 months.  Completed. Mary Austin, RN, CCRC
 FABULOUS  Dr. Tracey Callister Jason H. Cole, MD, MSc, FACC  Trial to compare and contrast the clinical costs and outcomes of the symptomatic patients undergoing initial diagnostic coronary artery disease evaluation strategies by CCTA or myocardial perfusion scanning. Completed.  Ruth Wagner, RN, CRC
 INTENSE  Invatec Frank T. Bunch, MD, FACC, FSCAI Sub Investigators: Dr. Brian D. Dearing & Dr. McLean Trotter. A prospective, multicenter, non-randomized, single-arm trial. The primary objective of this study are to assess the safety and effectiveness of the Scuba Stent as compared to other FDA-approved iliac stents in subjects with symptomatic claudication or rest pain and angiographic confirmation of denovo or restenotic lesions in the common or external iliac artery. Completed.   Mary Austin, RN, CCRC
ROCKET-AF  Bayer Health Care Charles W. Parrott, MD, FACC, FSCAI  Sub Investigators: Dr. J. Andrew Morrow & Dr. Richard J. Chernick 
A Prospective, Randomized, Double-Blind, Double – Dummy, Parallel –Group, Multicenter, Event Driven , Non-Inferiority Study to Comparing the Efficacy and Safety of Fixed Doses of Once –Daily Oral Rivaroxaban (Bay 59-7939) With Adjusted –Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation. The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non- inferior to that of dose- adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial fibrillation as measured by the composite end point of stroke and non-CNS systemic embolism.  Completed.
 
SAPPHIRE WW Cordis Corporation Frank T. Bunch, MD, FACC, FSCAI Sub Investigator: Dr. Arthur G. Grant III / Dr. John M. Galla.
This is a multi-center, prospective, observational study of a carotid artery stent system and an embolic protection system. The primary objective of this study is to estimate the 30 day MAE rate of stenting (any death, stroke, or any MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). Completed.
Mary Austin, RN, CCRC
 IOP- 108  BRACCO Charles W. Parrott, MD, FACC, FSCAI  Sub Investigator: Dr. Jason H. Cole.
A Phase II Multicenter, Randomized, Double-Blind Dose Finding of Iopamidol Injection 370 in Multidetector Computed Tomographic Angiography (MDCTA) in Patients with Suspected Coronary Artery Stenosis. The primary objective is to determine the dose of iopamidol injection 370 to be infused in future phase III clinical testing when used for coronary MDCTA.  Completed.
 
 TRACER Schering Plough Charles W. Parrott, MD, FACC, FSCAI  Sub Investigators: Dr. J. Andrew Morrow & Dr. Richard J. Chernick 
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome. Thrombin Receptor Antagonist for the Clinical Event Reduction in Acute Coronary Syndrome. The primary objective is to evaluate the hypothesis that SCH 530348 when added to standard of care will reduce the incidence of artherothrombotic events relative to standard of care alone., as measured by the composite cardiovascular death, MI, stroke, recurrent ischemia with rehospitalization and urgent coronary revascularization. Completed.
 
 TRIDENT Biogen, Inc.
Charles W. Parrott, MD, FACC, FSCAI  Sub Investigators: Dr. J. Andrew Morrow & Dr. Richard J. Chernick 
A Randomized, Double-Blind, Placebo-Controlled, Parallel - Group Study to Assess The Effects of Intravenous BG9928 on Body Weight in Subjects with Acute Decompensated Heart Failure and Renal Insufficiency. The major objective to assess the effect of BG9928, when added to standard therapy, on the change in body weight at 24 hours following the first dose in subjects with hospitalized with Acute Decompensated Heart Failure and Renal insufficiency. Completed.
 
 TRILOGY Eli Lilly and Company
Charles W. Parrott,   Sub Investigators: Dr. J. Andrew Morrow & Dr. Richard J. Chernick 
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non ST – Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed – The TRILOGY ACS Study Syndrome Purpose: The primary objective of this study is to test the hypothesis that prasugrel an asparin is superior to clopidogrel and asparin in subjects whose study treatment is initiated within ten days of the Unstable/NSTEMI event , when medically managed , without acute coronary revascularization has been determined to be the best therapeutic option. Completed.
 
Vista 16
Anthera Pharmaceuticals, Inc.
Richard Chernick, MD, FACC
This is a double-blind randomized parallel group placebo controlled study in subjects presenting with an acute coronary syndromes (ACS). Subjects will be randomized to receive either study drug or placebo in addition to atorvastatin and standard of care. Completed.
 
Optivol: Care Pathway Study  Medtronic Dr. Charles W. Parrott, MD, FACC, FSCAI Sub Investigators: Dr. J. Andrew Morrow & Dr. Richard J. Chernick 
A prospective, Randomized, Mufti-center, Post-Market Clinical Trail to compare monthly verses quarterly review of Cardiac Compass Trends with Optivol for initiation of clinical action. Completed. 
 
PHYSICIAN SPOTLIGHT
Jason H. Cole, M.D.
MSc, FACC 

Clinical and Invasive Cardiology