Cardiovascular Clinical Trials

Hoag Heart & Vascular Institute is a key area of concentration for research at Hoag. As such, Hoag is committed to supporting clinical research which complements our patient care initiatives.

The clinical trials program at Hoag Heart & 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
  
• Stenting procedures and devices to treat peripheral arterial disease 
  

For more information about our cardiovascular clinical trials, please contact the research coordinators at 949-764-5587 or 949-764-5915.

Current Clinical Trials

Title of 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.

Title 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.

Title 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.

Title of Study: Zen Study: The Medtronic Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-optimal Response to PDE5 Inhibitors

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

There currently are no studies open for enrollment at this time.  Prior studies have included treatment to increase levels of cholesterol HDL-C in patients with recent acute coronary syndrome.

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.

Devices to Treat Peripheral Arterial Disease

There are currently no studies open for enrollment at this time.