Status:
TERMINATED
Assessment of Plaque Vulnerability Using a Novel Technique: Multi-spectral PhotoAcoustic Imaging.
Lead Sponsor:
Centre Hospitalier St Anne
Conditions:
Neurology
Eligibility:
All Genders
18+ years
Brief Summary
Identification of intraplaque haemorrhage using MRI is technically demanding and sometimes uncomfortable. Photoacoustic imaging is a new non-invasive technique combining multi-wavelength infrared lase...
Detailed Description
A total of 60 patients with stenosis grade of \> 70% and considered for endarterectomy will be recruited for additional imaging. Pre-operative PA/US and 3D MR imaging will be conducted. Two patient gr...
Eligibility Criteria
Inclusion
- Presence of at least one carotid plaque with a degree of stenosis 70% (NASCET), indication to surgery (endarterectomy),
- Patients with favourable anatomy criteria :
- x Cranio-caudal length of normal or long neck x Cervical adiposity weak or absent x Carotid bifurcation in usual situation (at the level of the mandibular angle or lower) x Normal genicity of subcutaneous tissues x Calcification of arterial moderate or absent
- Patients affiliated to the social health security system.
Exclusion
- Refusal to participate,
- any concomitant chronic condition hampering the realization of ultrasound scanner or MRI (allergy to gel, intolerance or contraindication to gadolinium).
- Unstable patients with plaque claudication inducing procedure acceleration.
- Patients with unfavourable anatomy criteria :
- x Cranio-caudal length of the neck very short x Significant cervical adiposity x Carotid bifurcation higher than the mandibular angle x High echogenic subcutaneous tissue x Calcification marked arterialH2020-ICT-29-2016 no. 731771 Ethics requirements x Patients with fat necks, Presence of extensive calcifications at the site of the stenosis.
- Patients unable to consent.
- Pregnant woman or breastfeeding woman
Key Trial Info
Start Date :
January 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04763603
Start Date
January 29 2019
End Date
March 17 2020
Last Update
February 21 2021
Active Locations (1)
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1
Sainte-Anne Hospital
Paris, Île-de-France Region, France, 75014