Feasibility Study to confirm the decision to skip post-dilation after Carotid Artery Stenting with the Casper Rx

JRCT ID: jRCTs032230193

Registered date:30/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: carotid artery stenosis
• Date of first enrollment: 30/06/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Observation for lumen of carotid stent using angioscopy

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tajima Yosuke
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)