Clinical Trials

Sharp offers numerous clinical trials related to heart. These trials are vital to finding and advancing heart treatment options and play a key role in saving the lives of more heart patients. Sharp is designated as a Quintiles Prime Site, which means that Sharp medical facilities play an enhanced role in global clinical research and the development of new and more effective medicines.

Carotid Disease Trial
Every year more than 700,000 people experience a new or recurrent stroke. Approximately 20 to 30 percent of strokes are believed to be caused by carotid artery atheroscierosis or plaque build up in the carotid artery.

Carotid stenting is a minimally invasive procedure performed to open the narrowing caused by the plaque build-up. During the procedure, a catheter is threaded to the narrowed artery in the neck. A filter is then deployed to catch any loose particles dislodged by the procedure and then a stent is placed in the artery to keep it open. Sharp HealthCare is participating in a clinical trial to test the safety and efficacy of carotid stents and filters.

The SAPPHIRE Study 
Stenting and angioplasty with protection in patients at high-risk for endarterectomy. It will use the PRECISE Nitinol Stent System and the Angioguard XP/RX Emboli Capture Guidewire.

About the Devices Used

• Angioguard XP/RX Emboli Capture Guidewire System — designed to reduce distal embolization while maintaining blood flow during angioplasty and stent procedures.
• PRECISE Nitinol Stent System — intended for use during an interventional carotid artery stent procedure. The PRECISE stent is a permanently implantable device and is intended to keep the blood vessel open. The PRECISE Nitinol Stent System is indicated for use in conjunction with the Angioguard XP/RX Emboli Capture Guidewire.

Description 
Angioguard XP/RX Emboli protection system and PRECISE stent received FDA approval for 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 percent with neurological symptoms or stenosis of >80 percent without neurological symptoms. This study will enroll any patient who qualifies. Neurological examinations will be performed pre-procedure, before hospital discharge and at 30 days post procedure. Additionally, patients will be followed for up to one year.

For More Information
To learn more about this clinical trial, please call 619-370-0983. For more information about heart and vascular care at Sharp or to find a Sharp-affiliated doctor, search for a San Diego cardiologist or call 1-800-82-SHARP (1-800-827-4277), Monday through Friday, 8 am to 6 pm. To find general information about heart and vascular care, visit Cardiovascular Diseases in Adult Health or read the Heart and Cardiovascular News archive.