Status:
ACTIVE_NOT_RECRUITING
Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
Rationale: Approximately 15-20% of strokes originates from an atherosclerotic plaque rupture in the carotid artery. To reduce the risk of stroke, patients should be evaluated for possible carotid enda...
Eligibility Criteria
Inclusion
- Adult male or female (≥18 years old);
- Informed consent form understood and signed, and patient agrees to follow-up visits;
- Presence of carotid artery stenosis (between 30%-69%) according to conventional duplex measurements (peak-systolic velocity of 125-230 cm/s \[5\] in combination with visible lumen reduction \>30% according to North American Symptomatic Carotid Endarterectomy Trial \[NASCET\] method);
- Defined asymptomatic with respect to the ipsilateral carotid artery stenosis.
Exclusion
- A planned carotid revascularisation for the ipsilateral carotid artery stenosis at date of inclusion;
- History of carotid revascularisation at artery under investigation;
- Visible near occlusion at asymptomatic stenosis side according to conventional duplex measurements;
- Life expectancy \< 2 years;
- Participating in another clinical study, interfering on outcomes
Key Trial Info
Start Date :
April 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT05270005
Start Date
April 7 2022
End Date
December 1 2026
Last Update
February 12 2025
Active Locations (2)
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1
Rijnstate Hospital
Arnhem, Netherlands
2
Radboud university medical center
Nijmegen, Netherlands