Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice

Launched by DUK-WOO PARK, MD · Jun 21, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe the Ultimaster™ Tansei™ stent is for treating coronary artery disease in everyday medical practice. The study aims to gather information about how well this stent works when used by doctors in their routine care, rather than just in a controlled research environment. They are currently recruiting participants who are at least 19 years old and will be receiving this specific type of stent. It's important that patients or their guardians agree to participate in the study and follow up with the required check-ups.

To be eligible for this trial, patients should not be using any other types of drug-eluting stents, and they should not have a serious illness that limits their life expectancy to less than a year or be in a critical medical condition like cardiogenic shock. Those who join the study can expect regular follow-ups to monitor their health after receiving the stent. This trial is essential for understanding how well the Ultimaster Tansei stent performs in real-life situations and can help improve treatment options for patients with coronary artery disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients ≥ 19 years old
• • 2. Patients receiving Ultimaster™ Tansei™ stents.
• • 3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
• Exclusion Criteria:
• • 1. Patients with a mixture of other drug-eluting stents (DESs)
• • 2. Terminal illness with life-expectancy ≤1 year.
• • 3. Patients with cardiogenic shock