Researching different treatments - including medications, devices, therapies, etc. - allows our team to bring patients the most advanced therapies. A number of clinical trials aimed at developments in cardiac care are in progress at PeaceHealth St. Joseph Medical Center. These trials are national and international studies in which data and outcomes from multiple sites are compiled.
We are currently enrolling in the following investigational studies:
Sapphire WW Study: Carotid stent registry study to collect medical data about patients receiving a carotid stent for narrowed carotid (neck) artery or arteries. These are patients who, due to their health conditions, are at high risk for carotid artery surgery. These patients must meet the Medicare guidelines for having a carotid stent placed in combination with an embolism protection device, a filter basket designed to catch material (blood clots and fatty material). The devices used in this study have been approved by the Food and Drug Administration (FDA). There will be approximately 10,000 subjects enrolled from approximately 275 clinical sites in the United States, Canada, Latin America, Europe and Asia Pacific.
EXPERT CTO - Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions: The main objectives of this study are to assess the safety and effectiveness of a set of devices in the treatment of totally blocked off coronary arteries, also referred to as chronic total occlusions (CTOs). The devices to be used in this trial are: XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent systems, HT Progress and HT Pilot guide wires, and the MINI-TREK Coronary Dilatation Catheters. All of these devices have been granted FDA clearance, however are being tested for a “new indication” (the treatment of chronic total occlusions). Enrolled patients will participate in clinical and telephone follow-up for up to 5 years post-procedure. Approximately 250 patients, at up to 25 sites in the United States, will be enrolled in this trial.
LSR of Acuity - Longitudinal Surveillance Registry of the Acuity™ Spiral Lead: Patients who have received an FDA approved cardiac resynchronization therapy device (an implanted pacemaker that balances the function of both the left and right heart) including the Acuity Spiral lead are invited to participate in a study utilizing a bedside communicator called the LATITUDE® Patient Management System to help their doctor monitor their heart condition. There is nothing investigational about this study, which will provide long-term information on the safety and effectiveness of this technology. The study hopes to recruit approximately 1700 patients at 150 clinics across the country. Each patient will be followed for 5 years.
CANOPY Study: Carotid stent registry study to collect medical data about patients receiving a carotid stent for narrowed carotid (neck) artery or arteries. The main objective of the CANOPY trial is to assess the continued safety and effectiveness of the Rapid Exchange Acculink Carotid Stent System (RX Accunet CSS) in subjects at standard risk for adverse events from Carotid Endarterectomy. These patients must meet the Medicare guidelines for having a carotid stent placed in combination with an embolism protection device, a filter basket designed to catch material (blood clots and/or fatty material). The devices used in this study have been approved by the Food and Drug Administration (FDA). There will be approximately 1,200 subjects enrolled from approximately 350 clinical sites in the United States.
For more information on other clinical studies, please contact our Research Department at (360) 543-7609.