Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653387
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-20
Brief Title:
A Single-arm Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Single-arm Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System 80cm When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System NPS in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization TCAR Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate acute device and technical success of the CGuard Prime Carotid Stent System 80cm when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy
Detailed Description:
This study is a prospective multi-center single arm pivotal study The study shall not be blinded prior to during or following the procedure Patients undergoing transcarotid artery revascularization will be screened against the study inclusionexclusion criteria If the patient meets study eligibility requirements they shall be invited to participate provide informed consent and shall subsequently be assigned a study ID number
Enrollment will be a minimum of 50 evaluable pivotal patients A maximum of 20 of patients will be enrolled at any single site The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment
An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued maximum of 24 roll-in patients total assuming one primary physician operator per site
This study does not duplicate any current knowledge existing today on use of the CGuard Prime 80 used in conjunction with the ENROUTE NPS in the United States
Enrollment will be a minimum of 50 evaluable pivotal patients A maximum of 20 of patients will be enrolled at any single site The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment
An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued maximum of 24 roll-in patients total assuming one primary physician operator per site
This study does not duplicate any current knowledge existing today on use of the CGuard Prime 80 used in conjunction with the ENROUTE NPS in the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None