Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02657707|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Last Update Posted : April 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis||Device: Roadsaver™ Carotid Artery Stent Device Device: Nanoparasol® Embolic Protection System||Not Applicable|
Up to 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)|
|Actual Study Start Date :||April 21, 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||March 2024|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657707
|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|