Ignite Creation Date:
2024-05-06 @ 1:17 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03985774
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2019-06-10
Brief Title:
The ENROUTE Transcarotid Neuroprotection System ENROUTE Transcarotid NPS DW-MRI Study
Sponsor:
Silk Road Medical
Organization:
Silk Road Medical
Study Overview
Official Title:
The ENROUTE Transcarotid Neuroprotection System ENROUTE Transcarotid NPS DW-MRI Study
Status:
COMPLETED
Status Verified Date:
2021-04
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 OUS
Brief Summary:
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions relative to baseline and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure
Detailed Description:
The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the European Union The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease in the context of this study
This is a prospective single-arm multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions relative to baseline and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure
A patient is considered enrolled after
1 meeting all inclusion and none of the exclusion criteria
2 the transcarotid arterial sheath has entered into the patients vasculature Insertion of the venous sheath does not qualify a patient as enrolled
Patients who are screened but do not meet all study criteria are considered screen failures and may not be enrolled Patients in whom an arterial sheath is placed but who do not meet all study entry criteria are considered enrolled
The Investigator is responsible for maintaining any information pertaining to the Ethics Committee review and approval as required by local law
This is a prospective single-arm multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions relative to baseline and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure
A patient is considered enrolled after
1 meeting all inclusion and none of the exclusion criteria
2 the transcarotid arterial sheath has entered into the patients vasculature Insertion of the venous sheath does not qualify a patient as enrolled
Patients who are screened but do not meet all study criteria are considered screen failures and may not be enrolled Patients in whom an arterial sheath is placed but who do not meet all study entry criteria are considered enrolled
The Investigator is responsible for maintaining any information pertaining to the Ethics Committee review and approval as required by local law
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None