First Coast Cardiovascular Institute is committed to offering our patients the latest developments in medicine, while at the same time providing our patients with the highest quality of patient care. One of the ways we accomplish this goal is through clinical trials. Clinical trials, after all, are at the heart of all medical advances. The Research Department was started in 2007 with the guidance of Mary Hudson, RN, who laid the foundation to make the department what it is today. FCCI has been involved in many pre-market stent trials which have since been FDA approved, including Abbott’s Absolute Pro Iliac Stent, Abbott’s Omni Link Iliac Stent, Abbott’s Angioguard Emboshield Carotid Protection Device, Endeavor Coronary Stent, Everflex SFA Stent. We have also been involved in pre-market drug trials, like our work with Xarelto, which have since been FDA approved. We are also proud to say that FCCI also participated in a pre-market trial for the Zilver PTX, the world’s first and only SFA drug-eluting stent for the peripheral arteries. Now three years later, FCCI was selected as one of the first sites in the Southeast to implant the Zilver PTX stent, which combines the benefits of both mechanical and drug therapies. The data shows a clear drug effect by reducing reintervention rates by 53% compared with bare metal stenting. FCCI wants to help our patients benefit from this exciting technology.
WHAT IS A CLINICAL TRIAL?
Research studies involving people are called clinical trials. Clinical trials allow advances in medicine and identify new treatments for patients. Clinical studies provide patients access to innovative and cutting-edge technology. The Institutional Review board (IRB) oversees the site where the clinical research is conducted, reviews the ethics and safety of each study, and protects the rights and welfare of those who take part in clinical trials. As a participant in a clinical trial, you will have access to the Institutional Review board that is overseeing the research study and the physician and staff conducting the trial. The FDA supervises all aspects of the clinical research trials. Once the study is completed at all sites, all of the data is submitted to the FDA for approval.
WHO CAN PARTICIPATE IN A CLINICAL TRIAL?
As a patient at FCCI, you may be asked if you’d like to participate in a research study. A member of our Research Team will review the study with you, including any medical procedures to be conducted, frequency of study visits, and any potential risks and benefits of participating in the study. Research personnel will answer all your questions before you decide whether to volunteer to be part of the study. Each clinical trial is different and has very specific entrance guidelines. To be eligible to participate in a study, you must meet the criteria specified by the study protocol. Talk to your doctor, or ask to speak with a Research Coordinator about volunteering to participate in clinical trial.
HOW WILL I KNOW WHAT TO EXPECT BEFORE AND DURING THE RESEARCH STUDY?
Informed consent is an ongoing process to help you understand what is involved in taking part in a research study. As such, the research team will explain the following items to you:
- The purposes and description of the study
- The test, treatments, and procedures to be performed, including any that are experimental (new and not fully tested)
- How long the study will last
- Possible benefits and risks
- Other treatments and options
- How your privacy will be protected
- Who to contact for answers to your questions
- That taking part in a study is strictly your choice
Below you will find a list of our current enrolling studies:
|STUDY||SPONSOR||TYPE OF STUDY|
|Tigris||W.L. Gore||Superficial femoral artery stent study|
|OPEN||Flexible Stenting||Superficial artery stent study|
|DPAS||Covidien||Post market superficial femoral artery stent study|
|RESCUE||Bard||Instent restenosis (narrowing) of bare metal stent in arteriovenous fistula or graft|
|Multisense||Boston Scientific||Congestive heart failure study , additional software to detect early onset CHF|
|Analyze ST||St. Jude Medical||Fortify ST monitoring feature to detect clinical events in the Fortify ST ICD system|
|Sapphire||Cordis||Post market carotid stent study|
|Freedom||W.L. Gore||Registry data collection when using gore flow reversal and distal embolic filter|
|BRIDGE||Duke||Patients on coumadin with afib/aflutter undergoing procedures who has to stop their coumadin|
|ePAD||Daiichi Sankyo||Randomized patients with PAD to edoxaban vs. clopidogrel + aspirin|
|JET Registry||Medrad||Registry collect data on the use of JET stream navitus|
|Format||Cook Medical||Iliac Stent Study|
|EUCLID||Astra Zeneca||Randomized patients with PAD to Ticagrelor vs. Clopidogrel|