臨床研究等提出・公開システム

Japanese

Date of registration	June. 30, 2023
Last modified on	April. 16, 2024
Trial ID	jRCTs032230193

Scientific Title	Feasibility Study to confirm the decision to skip post-dilation after Carotid Artery Stenting with the Casper Rx by intravascular ultrasound and angioscopy
Public Title	Feasibility Study to confirm the decision to skip post-dilation after Carotid Artery Stenting with the Casper Rx

Contact for Scientific Queries	Name	Tajima Yosuke
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677
	Telephone	+81-43-222-7171
	E-mail	ccka1446@chiba-u.jp
Contact for Public Queries	Name	Tajima Yosuke
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677
	Telephone	+81-43-222-7171
	E-mail	ccka1446@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 30, 2023
Actual date of first enrollment
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		carotid artery stenosis
Intervention(s)		Observation for lumen of carotid stent using angioscopy
Health Condition(s) Keyword		carotid artery stenosis
Intervention(s) Keyword		angioscopy
Health Condition(s) Code		I65.2
Intervention(s) Code		D020677
Primary Outcome(s)		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(s)		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

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Clinical Research Initiation-Fund (of Chiba University Hospital)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	June. 19, 2023

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 16, 2024	(this page)	Changes
1	June. 30, 2023	Detail

List of change history