Safety and effecacy of the Anchor Wire
Phase 1
- Conditions
- cerebrovascular disease
- Registration Number
- JPRN-jRCTs052200012
- Lead Sponsor
- Sakai Nobuyuki
- Brief Summary
Primary ) Hemorrhagic complications did not occur because the test device was stable without unexpected movements. Secondary ) 1) Two cases of ischemic stroke occurred in 2 events (20%). It was not a device-related adverse event, but a cerebral infarction due to thrombosis of a cerebral aneurysm. 2) No arterial dissection 3) Vasospasm 1 event, asymptomatic mild vasospasm was confirmed by angiography. 4) Other adverse events 2 cases, 2 events (20%) hoarseness 1, puncture hematoma 1
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
(1) patients who need to exchange devices for endovascular therapy during intervention.
(2) patients aged between 20years and 80years old.
(3) patients who concented to the study in writing.
Exclusion Criteria
none
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hemorrhagic stroke
- Secondary Outcome Measures
Name Time Method ischemic stroke, success of exchange catheters, arterial dissection, vasospasm