Brief Summary:
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.
Primary Objective:
To evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment
Devices Used in Trial:
- The Roadsaver™ system consists of self-expanding nickel titanium (Nitinol) stent implant and a rapid exchange (RX) delivery catheter. The self-expanding implant is designed to expand to a pre-determined diameter when deployed by the delivery catheter. The implant is produced with various outer diameters ranging from 5-10 mm and with lengths of 20-40 mm. Upon exiting the delivery catheter at the target lesion, the implant expands to conform to the vessel lumen diameter.
- The Nanoparasol® embolic protection system is designed to capture and remove dislodged debris during a carotid interventional procedure. When the interventional procedure is complete, a retrieval catheter is advanced over the guidewire to close and capture the filter before the entire assembly is withdrawn from the patient.
Inclusion Criteria:
- Patient is between >21 and ≤80 years of age.
- Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
- Patient or authorized legal representative is willing to provide written informed consent prior to enrollment in study.
- Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy.
- Patient is either:
-
- Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; TIA or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; or
- Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology.
- Patient has a target lesion located at the carotid bifurcation and/or proximal ICA.
- Patient has a single de novo or restenotic (post CEA) target lesion or severe tandem lesions close enough that can be covered by a single Roadsaver™ stent.
- Patients having a vessel with reference diameters between 3.0 mm and 9.0 mm at the target lesion.
Principal Investigator: Joseph Tuma, M.D., FACC, FSCAI.
Dr. Tuma has been involved with cardiovascular clinical research since 2006. He completed his fellowship in cardiology from the Cardiac Center at Creighton University Medical Center in Omaha, NE. He completed his fellowship in interventional cardiology/endovascular medicine from the Cardiac Center at Creighton University Medical Center in Omaha, NE.
For more information, call Monument Health Clinical Research at 605-755-4326, email research@monument.health or visit https://clinicaltrials.gov/ct2/show/study/NCT02657707?term=CL11003&rank=1.
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