CONFIDENCE Trial Carotid Stent Trial to Evaluate the Safety and Efficacy of the Roadsaver™ Stent Used in Conjunction with the Nanoparasol® Embolic Protection System for Patients at Increased Risk for Adverse Events from Carotid Endarterectomy
ID Number 16-0438Principal Investigator(s)
Johanna T Fifi
Department(s) or Division(s)
The purpose of the CONFIDENCE Trial is to evaluate the safety and effectiveness of the Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® Embolic Protection System.
Patients may be asked to participate in this trial because they have been diagnosed with carotid artery stenosis (narrowing of your carotid artery). This narrowing is usually caused by a buildup of plaque. The patient's doctor may consider them for this trial because the patient is considered to be a high risk for a carotid endarterectomy (an operation where the inner lining of the carotid artery is removed).
Prior to entering the study, patients will be assessed by the study doctor at a screening visit and will inform the patient if they are qualified for the study. Once the patient is enrolled, they will be required to complete additional study visits over the course of 3 years. There are a total of seven (7) planned office visits including a screening visit, enrollment visit, and follow-up visits. The study visits will vary in length, but are expected to last approximately 2 hours each.
Recruiting Patients: Yes