Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT03982420
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2019-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
Sponsor:
Silk Road Medical
Organization:
Study Overview
Official Title:
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DW-MRI-US
Brief Summary:
The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions (relative to baseline) in patients treated with the transcarotid artery revascularization (TCAR) procedure.
Detailed Description:
This is a prospective, single-arm, multi-center evaluation of patients requiring carotid revascularization who are treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System. Both the ENROUTE Transcarotid NPS and ENROUTE Transcarotid Stent System have received CE mark and are commercially available in the European Union.
Patients enrolled in this study will have been offered the TCAR intervention as part of standard of care for the treatment of carotid artery stenosis, regardless of whether or not they agree to be in the study. Therefore, the act of participation in this procedure will not be the determining factor in whether or not the patient receives the TCAR treatment. Subject participation means they agree to undergo two additional DW-MRI imaging procedures immediately after the procedure and at 30 days to determine whether there is an increase in new white lesions. Any other procedure other than the active collection of consent and data by the sponsor is standard of care for the treatment of carotid artery stenosis.
These patients will be monitored to document the incidence of post procedure DW-MRI lesions (relative to baseline).
Patients enrolled in this study will have been offered the TCAR intervention as part of standard of care for the treatment of carotid artery stenosis, regardless of whether or not they agree to be in the study. Therefore, the act of participation in this procedure will not be the determining factor in whether or not the patient receives the TCAR treatment. Subject participation means they agree to undergo two additional DW-MRI imaging procedures immediately after the procedure and at 30 days to determine whether there is an increase in new white lesions. Any other procedure other than the active collection of consent and data by the sponsor is standard of care for the treatment of carotid artery stenosis.
These patients will be monitored to document the incidence of post procedure DW-MRI lesions (relative to baseline).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: