MY-01 study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2052220108

Enrollment

100

Registered

2022-10-19

Start date

2022-09-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovascular intervention in the coronary /peripheral artery with a catheterization via FA

Interventions

Hemostasis at the femoral artery access site using a absorbable topical hemostatic agent.

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Device Success	—

Contacts

Public ContactSato

Cordis Japa Goudou Kaisha

kumiko.sato01@cordis.com+81-120-888-478

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026