Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis
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|ClinicalTrials.gov Identifier: NCT02657707|
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis||Device: Roadsaver™ Carotid Artery Stent Device Device: Nanoparasol® Embolic Protection System||Not Applicable|
A total of 295 patients will be enrolled for this study. All potential patients being considered for the study should have been diagnosed with significant carotid artery stenosis and be considered a high perioperative risk for carotid endarterectomy.
Patients will be evaluated through screening, pre-procedure, index procedure, post-procedure. Follow-up visits will be completed at 30 days, 6 months, and 12, 24, and 36 months post-procedure.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||295 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
Experimental: Single-arm, open label
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 of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.
Device: Roadsaver™ Carotid Artery Stent Device
The Roadsaver™ carotid artery stent system is indicated for use in patients with significant atherosclerotic disease of the carotid arteries.
Device: Nanoparasol® Embolic Protection System
The Nanoparasol® embolic protection system is indicated for use with a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries.
- All stroke, death, and MI [ Time Frame: At 30 days ]
- Ipsilateral stroke [ Time Frame: At 12 months ]
- Successful deployment of stent [ Time Frame: Procedure day ]
- Successful completion of procedure [ Time Frame: Procedure day ]
- Successful deployment and retrieval of embolic protection device [ Time Frame: Procedure day ]
- Target lesion revascularization (TLR) [ Time Frame: At 6 and 12 months ]
- In-stent restenosis [ Time Frame: At 6 and 12 months ]
- Major stroke [ Time Frame: At 30 days ]
- Minor stroke [ Time Frame: At 30 days ]
- Transient ischemic attack (TIA) [ Time Frame: Within 30 days ]
- Neurologic death [ Time Frame: At 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657707
|Contact: Amy Waltersfirstname.lastname@example.org|
|Contact: Anne Hurleyemail@example.com|
|Principal Investigator:||Adnan Siddiqui, MD||University of Buffalo - Neurosurgery|
|Principal Investigator:||Chris Metzger, MD||Wellmont CVA Heart Institute|
|Principal Investigator:||Peter Schneider, MD||Kaiser Permanente Moanalua Medical Center|