carotid artery stenosis carotid artery stenosis
Conditions
Interventions
Observation for lumen of carotid stent using angioscopy
D020677
angioscopy
Sponsors
Tajima Yosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included. 1) Male or female 20 years old and more 2) Patients who are planned to treat with carotid artery stenting 3) Patients who are planned to perform pre-dilation using a balloon whose diameter is 4mm or more 4) Patients whose main organ function is kept 5) Patients who explained the study contents using explanatory documents and obtained written consent for study participation from the person
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not included. 1)Patients who need alternative consents due to dementia 2)Patients who have any allergies for the device planned to use 3)Patients who are considered inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the feasibility of angioscopy about the below 9 items. 1) Cerebral infarction due to plaque protrusion 2) Stent malposition 3) Vessel perforation 4) Arterial dissection 5) Device trouble 6) Heart failure 7) Air embolization 8) Increase in radiation exposure 9) Prolongation of operation time | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Agreement rate of plaque protrusion from IVUS and angioscopy 2) Agreement rate of need of post-diation from IVUS and angioscopy 3) Restenosis after 24 weeks 4) With or without of post-diation | — |
Contacts
Public ContactYosuke Tajima
Chiba University Hospital
Outcome results
None listed