Participation and leadership in clinical research is instrumental in remaining on the leading edge of technology and new medical therapies.  Cardiology Associates, through its physicians and clinical staff, participates in nationally sponsored clinical research in both the areas of interventional devices and drug studies contributing to the growing understanding of the heart and vascular system and to helping to advance the development of effective cardiovascular treatment.

As cardiovascular disease continues to be the number one cause of death and disability in the United States, it is important to remain on the cutting edge of technology and medical therapies. Cardiology Associates has participated in over 35 clinical trials and research studies covering many cardiovascular related areas including interventional devices, cardiovascular testing modalities, congestive heart failure, medical therapies, and preventive treatments.  It is our hope to provide results which  will make a contribution to our patients here at home as well as to global cardiovascular research.

Participation in clinical research is strictly voluntary and there are strict criteria and guidelines that must be met prior to enrollment in a study. If you are interested in learning more about or participating in a study please contact your physician or one of our clinical research coordinators.

 

Ruth Wagner, RN, CRC
rwagner@cardassoc.com

Mary Austin, RN, CCRC
maustin@cardassoc.com

 
 
 

Cardiology Associates is actively involved in the following trials.

Copper A Trial - Enrolling 

The purpose of the COPPER –A trial is to asses the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention and restenosis in  infrainguinal de novo, restonotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.

Sponsor: Horizons International Peripheral Group, LLC

Principal Investigator:  Frank T. Bunch MD, FACC, FSCAI

Coordinator: Mary Austin, RN, CCRC


CREDENCE - Enrolling

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.

Sponsor:  NIH

Principal Investigator: Jason H. Cole, MD, MSc, FACC

Sub Investigators: M. Wail Hashimi, MD, FACCand Kellan E. Ashley, MD, FACC, FCCP

Coordinator: Ruth Wagner, RN, CRC


Gore ISR Study - Enrolling

To evaluate post-market safety and effectiveness of Gore Viabahn for treatment of in-stent restenosis.

Sponsor:  W. L. Gore

Principal Investigator: Frank T. Bunch, MD, FACC, FSCAI

Coordinator: Mary Austin, RN, CCRC


Impella RP - Enrolling

HDE for Abiomed right heart impella.

Sponsor:  Abiomed

Principal Investigator: M. Wail Hashimi, MD, FACC

Sub Investigators: John M. Galla, MD, FACC and Kellan E. Ashley, MD, FACC, FCCP

Coordinator: Ruth Wagner, RN, CRC


Commander / RIVAROX HFA 3001 - Enrolling

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.

Sponsor:  Janssen

Principal Investigator:  Kenneth M. Burnham, MD, FACC

Sub Investigators: Jason H. Cole, MD, MSc, FACC & Stephanie Cleveland, PA

Coordinator: Ruth Wagner, RN, CRC


Cardiology Associates participated in the following integral trials.

ARTEMIS 

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.

Sponsor:  AstraZeneca

Principal Investigator:  Jason H. Cole, MD, MSc, FACC

Sub Investigators: M. Wail Hashimi, MD, FACC and Kellan E. Ashley, MD, FACC, FCCP and Robin Bates, PA-C

Coordinator: Ruth Wagner, RN, CRC


Copper Trial-B Trial 

The purpose of COPPER-B trial is to assess 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, teh OPC.

Sponsor:  Horizons International Peripheral Group, LLC

Principal Investigator:  Frank T. Bunch, MD, FACC, FSCAI

Coordinator: Mary Austin, RN, CCRC


EVOLVE 

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.

Sponsor:  Boston Scientific

Principal Investigator:  Erik A. Eways, MD, FACC

Coordinator: Ruth Wagner, RN, CRC


EXCITE Trial

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.

Sponsor:  Spectranetics Corporation

Principal Investigator:  Frank T. Bunch, MD, FACC, FSCAI

Coordinator: Mary Austin, RN, CCRC


Lutonix ISR

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.

Sponsor:  Bard/Lutonix

Principal Investigator:  Frank T. Bunch, MD, FACC, FSCAI

Coordinator: Mary Austin, RN, CCRC


MIMICS-2 Study

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.

Sponsor:  Veryan Medical

Principal Investigator:  Frank T. Bunch, MD, FACC, FSCAI

Coordinator: Mary Austin, RN, CCRC


TIGRIS 

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.

Sponsor:  W. L. Gore

Principal Investigator:  Frank T. Bunch, MD, FACC, FSCAI

Coordinator: Mary Austin, RN, CCRC