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High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)

Study acronym: CARESTAR
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 31, 2031 to May 31, 2032
    • Start date changed from estimate of Nov 1, 2025 to Mar 1, 2026
    • Study completion date: Jan 1, 2032 to Jun 2032
    v3
  2. Notable Start date: Oct 1, 2025 to Nov 1, 2025
    • Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study title expanded, about 10 words
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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Goal is to analyse the clinical safety and efficacy of the CARESTO® heal Stent within standard clinical routine for the treatment of patients with symptomatic non-stenotic carotid disease (SyNC) and with high-risk plaque features for stroke recurrence compared to medical treatment alone with respect to the mid- and long-term clinical outcomes.
Trial Details
NCT Number NCT07166731
Lead Sponsor Acandis GmbH
Conditions
(from sponsor)
Carotid Artery Disease, Symptomatic Carotid Artery Stenosis, Carotid Artery Stenting, Carotid Plaque Imaging, Embolic Stroke of Undetermined Source, Carotid Artery Thrombosis
Related terms Carotid Artery Diseases, Carotid Artery Thrombosis, Carotid Stenosis
Enrollment 536 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov