Research
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.
Active Studies
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.
CHOICE 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 5,000 subjects enrolled from approximately 500 clinical sites in the United States, Canada, Latin America, Europe and Asia Pacific.
PFAST CTOs Clinical Study - PERIPHERAL FACILITATED ANTEGRADE STEERING TECHNIQUE IN CHRONICTOTAL OCCLUSIONS: This study’s main objective is to demonstrate the safety and effectiveness of three new medical devices (called investigational devices), manufactured by BridgePoint Medical, in the facilitation of opening totally blocked off (“total occluded”) peripheral arteries, also known as CTOs. Patient’s will receive interventional treatment regardless of their involvement in this study, however consent allows your physician to utilize the BridgePoint system and allows our staff to evaluate your condition at 30 days post-procedure. All three devices, the CrossBoss/BigBoss™ Catheter, the Stingray/Mantaray™ Orienting Balloon Catheter , and the Stingray/Mantaray Guidewire have been granted FDA clearance for a “general indication,” however the purpose of this study is to gain FDA approval for their use in the opening of “chronically total occluded” peripheral arteries. Up to 100 patients presenting with peripheral CTOs at up to 10 clinical sites within the United States, will be enrolled in this study.
RESTORE AV: The Restoration of Atrioventricular Synchrony Trial
Your heart is made up of four distinct chambers, two atria and two ventricles. These chambers work together when your heart contracts to allow blood to be pumped throughout the rest of your body. The objective of this trial is to observe the effects and benefits of restoring atrioventricular (AV) synchrony, synchrony between the atrial and ventricular contractions, in subjects with prolonged PR intervals. Patients with an indication for an implantable cardioverter defibrillator will be implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device and will be randomized to one of two programming modes: one that affects atrial-ventricular timing and one that does not. Subjects who are enrolled will then participate in clinical follow-up for a total of 1 year after their device implantation. The RESTORE AV trial will enroll up to 24 subjects at a maximum of 6 centers throughout the United States.
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.
EXCITE ISR: Peripheral vascular disease of the leg can cause pain, burning or cramping in the muscles of the thigh, calf and foot, and/or non-healing wounds due to poor blood flow through the femoropopliteal artery (the main artery entering the leg). This condition may be treated by placing a small, tubular screen (called a stent) to prop open the artery to keep blood flowing. Patients who have previously been treated in this way may experience a progression of their disease, resulting in a new blockage in the area of the stent. These patients will be invited to participate in a study that examines the use of laser catheters to treat the in-stent blockage. The laser catheters are approved by the FDA to treat blockages in the arteries of the legs, but not specifically to treat blockages within a previously placed stent. Over 350 patients will be enrolled in the study in the United States. Patients will follow-up in the clinic for approximately 1 year.
ORBIT II: The plaques that may develop within the arteries of the heart (coronary artery disease) reduce blood flow that the heart muscle needs to effectively pump blood. Some of these plaques become hardened with calcium, making treatment of these blockages challenging. Patients who consent to participate in the ORBIT II study will undergo a procedure to open up these blocked coronary arteries using a device that is threaded into the blocked artery and spins at high speed to grind away the hardened plaque. This may increase the success of balloon angioplasty and/or stent placement in restoring blood flow to the heart muscle. A similar device is already FDA approved to treat blockages in the arteries of the legs, but is considered investigational in this study because it is being used to treat coronary artery disease. Data regarding safety and effectiveness will be collected for each patient for up to one year. Up to 429 patients will be enrolled at up to 50 clinical centers across the United States.
For more information on other clinical studies, please contact our Research Department at (360) 543-7609.
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