Clinical Trials / Research
 "We at Hoag recognize the need to bring vital research within the reach of our community residents. Our multidisciplinary team, including cardiologists, neurologists, radiologists, ECU physicians, vascular and cardiovascular surgeons, cath lab team, nursing team, pharmacy and clinical laboratory departments, and research coordinators are trained and very committed to providing the best care possible to support clinical research."
Subbarao Myla, MD, Medical Director of Cardiovascular Research
Hoag Heart and Vascular Institute is one of Hoag's Centers of Excellence. As such, Hoag is committed to supporting clinical research which complements our patient care initiatives.
The clinical trials program at Hoag Heart and Vascular Institute includes numerous industry sponsored studies to include medical devices and drugs. Major areas of focus include carotid disease, cardiac imaging studies, techniques for testing and programming implantable cardiac defibrillators and pacemakers, and devices used during coronary angiography and stenting procedures.
For more information about our cardiovascular clinical trials, please contact the research coordinators at 949/764-5587 or 949/764-5915.
Carotid Disease
Annually 700,000 people experience a new or recurrent stroke. Stroke is the third leading cause of death behind diseases of the heart and cancer. An estimated 20-30% of strokes are believed to be due to carotid artery atherosclerosis or plaque build-up*. Carotid artery stenting is a minimally invasive procedure done to open the narrowing created by the plaque build-up. A catheter is threaded to the narrowed artery in the neck, a filter deployed to catch any loose particles dislodged by the procedure and then a stent is placed in the artery. The filter is removed and the patient is admitted to the hospital for observation. Hoag has participated in over 10 clinical trials, testing the safety and efficacy of carotid stents and filters. Below are the studies currently enrolling patients.
* Stroke statistics source: American Heart Association 2003 Update
Name of Research Study: Asymptomatic Carotid stenosis, stenting versus endarterectomy Trial - The ACT I Study
Title of Research Study: Carotid angioplasty and stenting versus endarterectomy in asymptomatic subjects who are at standard risk for carotid endarterectomy with significant extracranial carotid stenotic disease
Sponsor: Abbott Vascular Devices
Description: The purpose of this investigational study is to evaluate the safety and effectiveness of carotid artery stenting, using Emboshield® Embolic Protection System with the Xact® Carotid Stent System, when compared to the current surgical procedure – carotid endarterectomy (CEA) – for the treatment of asymptomatic carotid artery disease in standard risk subjects.
To participate in this study, the patient must not have had a stroke or TIA (transient ischemic attack or mini stroke) within the last 6 months and have carotid artery stenosis (narrowing) >70% and <99%. The patient must be less than 80 years old and also not have any medical condition, such as advanced congestive heart failure, unstable angina or severe lung disease, which deems them a high surgical risk. Other exclusion criteria may apply.
Follow-up will occur at 30 days, 6 months and annually up to 5 years after the procedure and may include a physical and neurological examination, laboratory tests, ECG, x-rays of the stent and a carotid ultrasound.
For more information about this trial, please contact the clinical research coordinators at 949-764-5587 or 949-764-5915.
Name of Study: A Carotid Stenting Boston Scientific Surveillance Program (Cabana)
Sponsor: Boston Scientific Corporation
Devices Used:
- Boston Scientific FilterWire EZ™ Embolic Protection System (FilterWire EZ System) – for use as a guide wire and embolic protection system to contain and remove embolic material while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
- Carotid WALLSTENT® Monorail® Endoprothesis (Carotid WALLSTENT Endoprostheis) – a carotid stent system intended for use during an interventional carotid artery stent procedure. The Carotid Wallstent is a permanently implantable device and is intended to re-establish and maintain vessel patency. The Carotid WALLSTENT Endoprosthesis is indicated for use in conjunction with the FilterWire EZ System.
Description: The Carotid WALLSTENT Endoprosthesis, used in conjunction with the FilterWire EZ System, is intended for the treatment of carotid artery stenosis in patients who are at high risk for adverse events from carotid endarterectomy (surgery to remove plaque from the carotid artery) and have a stenosis of >50% with neurological symptoms or stenosis of >80% without neurological symptoms. This study will enroll any patient with high risk medical conditions such as unstable angina, advanced congestive heart failure, or renarrowing of the carotid artery after prior carotid endarterectomy. Neurological examinations will be performed pre-procedure, before hospital discharge and at 30 days post procedure.
For more information about this trial, please contact the clinical research coordinators at 949-764-5587 or 949-764-5915.
Name of Study: Carotid Stenting for High Surgical-Risk Patients: Evaluating Outcomes Through the Collection of Clinical Evidence (CHOICE)
This post market study will enroll patients who are deemed high surgical risk with the percent stenosis listed below, without specific exclusion criteria. Neurological examinations will be performed pre-procedure, before hospital discharge and at 30 days post procedure.
Sponsor: Abbott Vascular
Devices Used: Emboshield® NAV6™ Rapid Exchange (RX) Embolic Protection System for use with Xact® Rapid Exchange Carotid Stent System or RX Accunet™ Embolic Protection System for use with RX Acculink® Carotid Stent System. The carotid stent systems have received FDA approval under Premarket Applications and the embolic protection systems have been cleared for commercial use under 510(k)s.
Description: These devices are used for the treatment of carotid artery stenosis in patients who are at high risk for adverse events from carotid endarterectomy (surgery to remove plaque from the carotid artery) and have a stenosis of >50% with neurological symptoms or stenosis of >80% without neurological symptoms. The embolic protection devices are designed to reduce distal embolization (particles of plaque that can break away) while maintaining blood flow during angioplasty and stent procedures. The stents are permanently implantable devices, intended to re-establish and maintain vessel patency.
Name of Study: Gore Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (Embolden)
Sponsor: W. L. Gore & Associates, Inc.
Description: This research study is being conducted to evaluate the safety and effectiveness of the Gore Embolic Filter (the study device) when used during the treatment of narrowing in the blood vessel in the neck (carotid artery) for subjects considered to be at high surgical risk for complications during carotid endarterectomy. The Gore device is used in conjunction with FDA approved carotid stents for treatment of carotid artery stenosis.
Patients who are eligible to enroll include those who have a stenosis of >50% with neurological symptoms or stenosis of >80% without neurological symptoms. They must also have some high risk criteria which may include age greater than 80, severe angina or congestive heart failure, severe pulmonary disease or restenosis after a carotid endarterectomy. Laboratory tests and an ECG will be done before and after the procedure. In addition, neurological examinations will be performed pre-procedure, before hospital discharge and at 30 days post procedure. The study is complete after a 30 day physical examination.
Name of Study: Sapphire WW – Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy
Sponsor: Cordis®, a Johnson & Johnson company
Description: This research study is being conducted to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease, utilizing the Cordis PRECISE® Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire.
Patients who are eligible to enroll include those who have a stenosis of >50% with neurological symptoms or stenosis of >80% without neurological symptoms. They must also have some high risk criteria which may include age greater than 75, severe angina or congestive heart failure, severe pulmonary disease or restenosis after a carotid endarterectomy. Neurological examinations will be performed pre-procedure, before hospital discharge and at 30 days post procedure. The study is complete after a phone call at one year.
Cardiac Imaging Studies
There currently are no studies open for enrollment at this time. Prior studies have included imaging agents used to detect myocardial ischemia (lack of oxygen to the heart muscle).
Techniques for Testing and Programming Implantable Cardiac Defibrillators and Pacemakers
There are currently no defibrillator or pacemaker studies open for enrollment at this time.
Drug Studies and Cardiovascular Disease
Name of Study: A phase III, double-blind, randomized placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS) – Protocol NC20971
Sponsor: F. Hoffmann-La Roche LTD
Principal Investigator: Subbarao Myla, MD
Description: This trial is a double-blind, randomized (like the flip of a coin), placebo-controlled, parallel group, multi-center study in patients recently hospitalized for Acute Coronary Syndrome. This study is being conducted to see if RO4607381 will decrease the risk of recurrent cardiovascular events (such as heart attack, stroke and cardiac death) in patients with recent acute coronary syndrome (ACS) by raising levels of HDL cholesterol. The study will also assess the long-term safety profile of RO4607381 and evaluation of the effect of RO4607381 on lipid metabolism and markers of inflammation and oxidation. Participating patients will be randomized one to one to receive either the study medicine RO4607381 or the inactive placebo substance. Neither you nor your doctor will know which substance you are taking (double-blind). The study will last for at least 2 years and up to 5 years. It will be conducted at the principal investigator’s office with lab specimens taken and processed for shipment at Hoag Hospital.
To be included in this research study, the following basic criteria must be met but is not limited to:
- Must be at least 45 years old.
- Been recently hospitalized for acute coronary syndrome.
- Additional criteria may apply.
Devices Used During Coronary Angiography and Stenting Procedures
There are currently no open and enrolling trials at this time. Previous studies have included drug eluting stents and filter systems.
This information is provided for educational purposes only and is not intended to replace the medical advice of your physician or healthcare provider. While we strive to keep our website current, medical practices sometimes change quickly. Please consult your healthcare provider for advice about a specific medical condition.
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