臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 19, 2022
Last modified on	June. 29, 2023
Trial ID	jRCT2052220108

Scientific Title	A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Absorbable Topical Hemostatic Agent (MY-01) in Hemostasis at Femoral Artery Access Site Following Percutaneous Catheterization Protocol
Public Title	MY-01 study

Contact for Scientific Queries	Name	Iida Osamu
	Affiliation	Kansai Rosai Hospital
	Address	3-1-69 Inabasou Amagasaki-shi Hyogoken Japan
	Telephone	+81-6-6416-1221
	E-mail	kumiko.sato01@cordis.com
Contact for Public Queries	Name	Sato
	Affiliation	Cordis Japa Goudou Kaisha
	Address	Shinjuku I-Land Tower 6-5-1, Nishi-Shinjuku Shinjuku-ku 163-1306 Tokyo, Japan
	Telephone	+81-120-888-478
	E-mail	kumiko.sato01@cordis.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Sept. 28, 2022
Actual date of first enrollment
Target sample size		100
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	(1) Patient is 20 years of age or older (2) Patient has provided a written informed consent (3) Patient is scheduled for endovascular intervention on a lesion in the coronary or peripheral artery with a catheter inserted through the common femoral artery (the index limb of this study will be either left or right) (4) Patient is scheduled for 5F, 6F or 7F puncture in the common femoral artery
	Exclusion Criteria	(1) BMI > 40 kg/m2 (2) STsegment elevation myocardial infarction over 48 hours prior to catheterization (3) Patient with diseases such as thrombocytopenia (< 100,000), von Willebrand's disease, symptoms of anemia (hemoglobin < 10 g/dL, hematocrit < 30%), and hemorrhagic disease (4) Prior vascular surgery in the ipsilateral femoral artery (5) Pre-existing systemic or groin infection
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Endovascular intervention in the coronary /peripheral artery with a catheterization via FA
Intervention(s)		Hemostasis at the femoral artery access site using a absorbable topical hemostatic agent.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Device Success
Secondary Outcome(s)

Primary Sponsor	Cordis Jaoan GK

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Syakai-Houjin Omichikai-Group Morinomiya Hospital
Address	2-1-88 Morinomiya, Joutou-ku, Oosaka-shi, Oosakafu, Osaka
Telephone	+81-6-6969-0111
E-Mail
Approval Status	Approval
Date of approval	Aug. 17, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 29, 2023	(this page)	Changes
1	Oct. 19, 2022	Detail

List of change history