Clinical Research

Deborah’s innovative Clinical Research Department is currently involved in over 30 innovative trials exploring new treatments and procedures in Electrophysiology, Interventional Cardiology, Peripheral Vascular Disease, and Preventive Cardiology. In addition to highly committed and talented Principal Investigators, the Clinical Research Team at Deborah provides superior patient support through its research associates, who keep both referring physicians and patients apprised of not only their progress, but that of the clinical research study, at each step of the way.

Pedram Kazemian, MD, MSc, FRCPC, FACP, Medical Director, Clinical Research

CREST-2 Stoke Prevention Study
Do you have narrowing in your carotid arteries? 

What is CREST-2?
CREST-2 is a study for people who have narrowing of their carotid artery, without stroke warning signs caused by that artery such as mini-strokes, temporary strokes called TIAs, temporary paralysis or numbness on one side of the body, temporary slurring of speech, or other temporary brain symptoms.

What is the purpose of CREST-2? 
CREST-2 is designed to compare three different methods of stroke prevention to find the safest and most effective treatment. The stroke prevention methods include intensive medical management alone compared to intensive medical management in combination with a procedure to reopen the carotid artery in your neck (called revascularization) for treatment of plaque buildup. The two procedures available in this trial are carotid endarterectomy (en-dar-ter-EK-ta-mee) and carotid stenting. All study participants will receive intensive medical management to help control their risk factors for stroke.

Why CREST-2?
CREST-2 physicians want to find the best way to prevent strokes. Over the past 20 years, medical management of stroke risk factors has improved such that risk of stroke from asymptomatic carotid stenosis has been significantly reduced. Carotid endarterectomy and carotid artery stenting (both revascularization procedures) have also improved. To date, no research has been conducted to compare the treatment differences between 21st century medical management and these two procedures.

CREST-2 is intended to compare the two procedures to intensive medical management with drugs and lifestyle modification in patients without recent stroke and without stroke warning signs. The information from this study will help us learn the best way to prevent strokes in other people like you.

Who may participate in CREST-2?
Men and women who:

  • Are 35 years and older
  • Have narrowing (70% or greater) of at least one of their carotid arteries
  • Lack other serious medical conditions

Method 1
Intensive medical management using aspirin to prevent blood clot formation, medications to reduce blood pressure and bad cholesterol (“LDL-cholesterol”), and management of lifestyle risk factors such as physical activity, weight loss, and alcohol and tobacco use to prevent stroke.

 

 

Method 2
Intensive medical management, as described in method 1, in combination with a procedure called carotid endarterectomy (en-dar-ter-EK-ta-mee). This procedure is the surgical removal of plaque buildup in the carotid artery in your neck to prevent stroke.

 

 

Method 3
Intensive medical management, as described in method 1, in combination with a procedure called carotid artery stenting. This procedure involves threading a small catheter through a blood vessel to place a small mesh scaffold—a stent—inside the vessel to push vessel walls open and hold them there so blood flows unobstructed to prevent stroke.

 

For more information contact Sarah Muchowski, BS, CREST-2 Research Coordinator (609) 893-1200 ext. 5019

The Radiance HTN Study

If you have Hypertension, you are not alone. Learn about a clinical study for the potential treatment of high blood pressure.

LUCY Study Focuses on Endovascular Treatment of Abdominal Aortic Aneurysms (AAAs) in Women Compared to Men

The LUCY study, “TriVascular Evaluation of Females Who are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair,” examines the potential for improved clinical outcomes associated with using the Ovation® Abdominal Aortic Stent Graft platform for endovascular repair of abdominal aortic aneurysms (EVAR) in women as well as men. The lack of adequate treatment options — primarily due to more conventional large bore EVAR systems — is a persistent issue for female AAA patients. Clinical literature shows that women diagnosed with AAAs experience aortic expansion at a rate that is 40-80% faster than men, which can result in aortic rupture at smaller diameters. Due to their smaller stature, women with AAAs also typically have smaller femoral arteries, resulting in more challenges with vascular access. Often there may also be hostile aortic neck anatomy, resulting in significantly decreased options for on-label EVAR treatment.

Principal Investigator Richard Kovach, MD, Chair, Interventional Cardiology and Director, Cardiac Catheterization Laboratory.

For more information, please contact Luot Lewis, LUCY Study Coordinator at 609-893-1200 ext. 5022.

MIMICS-2 Stent

Developed by Veryan and based on biomimicry, the new BioMimics 3D® stent technology involves adapting traditional straight stent designs to a patented three-dimensional helical shape, which more closely mimics the natural geometry of the human vascular system. BioMimics 3D technology is designed to enhance clinical performance by improving flow conditions and biomechanical performance of stented vessels. The advanced, biomimetic design of the BioMimics 3D stent is intended to provide more flexibility — as well as kink and fracture resistance, in comparison to other laser-cut nitinol tube stents — making its unique design of particular importance in the hostile environment of the femoropopliteal artery.

The BioMimics 3D stent has a unique helical curvature to impart natural geometry to the diseased artery, promoting secondary (swirling) flow and elevated hemodynamic shear stress, which has a protective effect on the endothelium. The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to enable coil-spring shortening of the stented segment during knee flexion and thus mitigate the risk of stented segment compression causing localized strains, which in a straight stent may lead to stent fracture and chronic vascular injury.

Principal Investigator: Vincent Varghese, DO, Attending, Interventional Cardiology and Endovascular Medicine; Research Coordinator: Alyssa Bates 609-893-1200 ext. 5019

Parachute® Ventricular Partitioning Device

This technology offers hope to those suffering from heart failure caused by damage to and weakening of the heart muscle following a heart attack.

Through a catheter inserted in the femoral artery, the Parachute implant is deployed in the left ventricle to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry efficiently and functionality.

Principal Investigator: Richard Kovach, MD, Chair, Interventional Cardiology and Jennifer Mazzoni, DO, FACC, Cardiology


For information on ongoing Clinical Trials or to refer your patient please contact Linda Dewey, RN, MSN, CCRC, Senior Study Coordinator, Department of Clinical Research at 609-893-1200 ext. 5023, Fax: 609-735-1472, Attention Linda. E-mail: DeweyL@deborah.org

Published in Cath Lab Digest

Percutaneous Intervention of a Complex Ventricular Septal Defect Author(s): Harit Desai, DO; Nemalan Selvaraj, DO; Ulrich Luft, MD and Jon C. George, MD; Division of Interventional Cardiology and Endovascular Medicine, Deborah Heart and Lung Center, Browns Mills, New Jersey

Clinical Research Department Awards

Published Research Deborah Has Participated In:

  • Patterns of Anticoagulation Following Bioprosthetic Valve Implantation: Observations from ANSWER