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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- InspireMD
- Enrollment
- 50
- Locations
- 8
- Primary Endpoint
- Acute device success
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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 inclusion/exclusion 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acute device success
Time Frame: From enrollment to end of follow-up at 1 year
Successful insertion of the delivery system, successful deployment of the CGuard Prime™ 80 stent, and successful retraction of the delivery system when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.
Technical success
Time Frame: From enrollment to end of follow-up at 1 year
Technical Success Rate is defined as the number of patients with at least one CGuard Prime™ 80 device successfully delivered and deployed with final residual diameter stenosis \< 30% following final post-balloon dilatation (if performed) divided by the total number of patients where CGuard Prime™ 80 device deployment was attempted when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.
Secondary Outcomes
- Procedural success(From enrollment to 30-day follow-up)
- Treatment success(From enrollment to 30-day follow-up)
- Occurence of Hierarchical Death, Stroke or Myocardial Infarction (DSMI) within 30 days of the procedure(From enrollment to 30-day follow-up)
- Hierarchical Death or Stroke rate within 30 days of the procedure(From enrollment to 30-day follow-up)
- Rate of death within 30 days of the procedure(From enrollment to 30-day follow-up)
- Rate of all strokes within 30 days of the procedure(From enrollment to 30-day follow-up)
- Rate of major stroke within 30 days of the procedure(From enrollment to 30-day follow-up)
- Rate of minor stroke within 30 days of the procedure(From enrollment to 30-day follow-up)
- Rate of Myocardial Infarction (MI) within 30 days of the procedure(From enrollment to 30-day follow-up)
- Rate of stent thrombosis or occlusion within 30 days of the index procedure(From enrollment to 30-day follow-up)
- Rate of stent thrombosis or occlusion through 1-year of the index procedure(From enrollment to end of follow-up at 1 year)
- All device-related serious adverse events within 30 days of the procedure(From enrollment to 30-day follow-up)
- All device-related serious adverse events through 1-year of the procedure(From enrollment to end of follow-up at 1 year)
- Rate of ipsilateral strokes between 31- and 365-day post index procedure(From time of 30-day follow-up to end of follow-up at 1 year)