- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763603
Assessment of Plaque Vulnerability Using a Novel Technique: Multi-spectral PhotoAcoustic Imaging. ((CVENT-PAI))
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ile De France
-
Paris, Ile De France, France, 75014
- Sainte-Anne Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the device
Time Frame: 18 month
|
The primary outcome is to evaluate the ability of the experimental device to visualize hemorrhage within the plaque.
The primary endpoint will therefore be concordance with histology and plaque analysis (ex-vivo reference method) and MRI (invivo reference method).
|
18 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of anatomical concordance
Time Frame: 18 month
|
The secondary objective of the study is to evaluate the concordance according to the anatomical characteristics of the patient.
However, only patients without unfavorable anatomy will be included in the study.
|
18 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D18-P007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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