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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

StatusRecruiting
PhaseNot applicable
SponsorInspireMD
Started
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Record History

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  1. Study sites: 1 to 8v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  3. Eligibility criteria revised
    • Secondary endpoints expanded, about 137 words
    • Study description expanded, about 169 words
    • Collaborators expanded, about 8 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
InspireMD
3 trials monitored
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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.
Trial Details
NCT Number NCT06653387
Lead Sponsor InspireMD
Collaborators: Washington University School of Medicine, TriHealth Inc., NAMSA
Conditions
(from sponsor)		 Carotid Artery Diseases
Related terms Carotid Artery Diseases, Carotid Stenosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov