MY-01 study

JRCT ID: jRCT2052220108

Registered date:19/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Endovascular intervention in the coronary /peripheral artery with a catheterization via FA
• Date of first enrollment: 28/09/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Hemostasis at the femoral artery access site using a absorbable topical hemostatic agent.

Outcome(s)

• Primary Outcome: Device Success

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Iida Osamu