Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT06767657
Description:
De-identified Participant-Level Data: Informed consent templates , CRF Baseline clinical characteristics, including NIHSS score, comorbidities, and ASA score.) Diagnostic results related to carotid stenosis.Treatment details, including timing of CEA (urgent vs. delayed) and any perioperative interventions.
Outcomes data, including: Incidence of stroke (all types), myocardial infarction, and death within 30 and 90 days.Neurological complications (e.g., ipsilateral ischemic stroke). Safety endpoints, including complications such as hemorrhagic stroke and other adverse events.
Detailed study protocol outlining eligibility criteria, interventions, and endpoints. Statistical analysis plans used to to evaluate primary and secondary endpoints.
Access will be granted after completion of the study and publication of the primary results.Requests must include a proposal for a secondary analysis, a data-sharing agreement, and a commitment to maintaining data confidentiality
Study:
NCT06767657
Study Brief:
Urgent Carotid Endarterectomy (CEA) Versus Delayed CEA in Symptomatic Carotid Stenosis (SPREAD-STACI II)