Carotid stenosis
Conditions
Interventions
OCT group:Intracarotid OCT
Sponsors
Changhai Hospital, the First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-85 years; 2. Patients who required OCT as a supplementary examination, e.g., (1) pre-stenting and/or immediate post-stenting evaluation of the carotid artery, and (2) follow-up of carotid artery stenting (CAS); 3. Subjects or their proxies voluntarily participate and sign an informed consent form and are willing to undergo relevant examinations and clinical follow-ups.
Exclusion criteria
Exclusion criteria: 1. Embolic protection system cannot be placed beyond 3 cm distal to the lesion segment; 2. Target vessels with severe calcification or tortuosity; 3. Internal carotid artery is too stenosis to passing; 4. Target vessels with total occlusion; 5. Presence of active bleeding, severe abnormal coagulation (prothrombin time (PT) or international normalized ratio (INR) 2 times higher than the upper limit of normal), platelet count less than 80 x 10^9/L or greater than 700 x 10^9/L; 6. Severe renal impairment (serum creatinine > 2.0 mg/dL); 7. Unstable arrhythmias, such as ventricular tachycardia, ventricular tachycardia, sick sinus syndrome; 8. New York Heart Association class III or IV heart failure; 9. In other clinical trials within the last 1 month; 10. The researcher judged that the patient is inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Qualified rate of the clear imaging length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ability to assess lesions (if applicable);Ability to assess immediate effect of stent deployment (if applicable);Ability to assess neointimal healing of post-CAS (if applicable);Postoperative neurological complications;Postoperative serum creatinine changes;In-hospital stroke and mortality;Adverse events related/possibly related to the study device;Adverse events related to OCT examination and contrast agents; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Changhai Hospital, the First Affiliated Hospital of Naval Medical University
Outcome results
None listed