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Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS

Study acronym: NOTICE-CAS
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Start date: Jan 1, 2024 to Apr 1, 2024
    • Interventions: Angio-CT of the neck and head with assessment of brain perfusion (Radiation), CAS (standard) (Procedure), CAS + Intravascular measuring the… to Angio-CT of the neck and head (Radiation), CAS (standard) (Procedure), CAS + Intravascular measuring the pressure gradient (Procedure)…
    • Study description expanded, about 30 words
    v3
  2. Notable Start date: Nov 1, 2023 to Jan 1, 2024
    • Primary endpoints: 11 to 13
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis. In 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis. Carotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems. OBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit. PRIMARY ENDPOINTS: 1. Assessment of cerebral perfusion by magnetic resonanse before and after CAS 2. Assessment of cognitive symptoms using before and after CAS 3. Assessment of neurological symptoms before and after CAS 4. Assessment of otolaryngological symptoms before and after CAS SECONDARY ENDPOINTS: Creation of a non-invasive computed tomography protocol with pressure gradient assessment in patients with carotid artery stenosis. A final version of the algorithm based on a new diagnostic measurement (concentration gradient) ready to be used in the diagnosis of CAS-eligible patients with an implemented function for automatic classification of measurement results that will indicate the group of patients who will benefit from the CAS procedure.
Trial Details
NCT Number NCT06123767
Lead Sponsor 4th Military Clinical Hospital with Polyclinic, Poland
Collaborators: Medical Research Agency, Poland
Conditions
(from sponsor)
Carotid Artery Stenosis, Carotid Artery Stenting, Stroke
Related terms Apraxias, Carotid Stenosis, Stroke
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov