CGUARDIANS III IDE Pivotal Trial
ConditionCarotid Artery Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-82
SponsorInspireMD
About this trial
This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery Revascularization procedures using the CGuard Prime Carotid Stent System 80 in the treatment of carotid artery stenosis in patients at high risk for complications from CEA.
Eligibility criteria
Qualifiers
Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
Disqualifiers
Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure
Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure
Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
Previously placed stent in the ipsilateral ICA or CCA
Trial design
Treatments tested in this trial
- SwitchGuardTM NPS
Treatment groups
103 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov