Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial
NCT03179774 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-07-28
Summary
Revascularization for carotid artery occlusion (CAO) remained controversial, there is no prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO patients. The investigators conduct a prospective study composed of clinical registry arm and RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and thereafter up to 12 months.
Conditions
- Carotid Occlusion
Interventions
- DEVICE
-
Endovascular revascularization
All interventions will be performed via 8F femoral sheath. Target common carotid artery will be engaged with 8F JR 4 guiding catheter. Intra-luminal wiring using coronary guidewires and microcatheters or alternative subintimal tracking with antegrade re-entry technique. Wiring would be abandoned after 30 minutes of futile effort, consumption of more than 300 ml of contrast, or when the wire tip is confirmed to be extravascular. Once wire enters distal true lumen, the microcatheter was exchanged to a 1.5 mm diameter coronary balloon for pre-dilatation. Distal embolic protection device would be deployed if an adequate landing zone can be identified. Properly sized balloon expandable stents and self-expanding stents were then deployed to scaffold the occlusion. Balloon post-dilatation may be done if stent expansion was inadequate.
Sponsors & Collaborators
-
National Taiwan University Hospital
lead OTHER
Principal Investigators
-
Hsien-Li Kao, MD · National Taiwan University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-17
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Taiwan
Study Locations
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