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

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: Ultimaster™ Tansei™ stents

• Registration Number: NCT04443530
• Lead Sponsor: Duk-Woo Park, MD

Brief Summary

This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent in the "real-world" daily practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-21
• Study First Posted: 2020-06-23
• Study Start: 2020-09-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary artery stenosis	Ultimaster™ Tansei™ stents	Patients with coronary artery disease

Primary Outcome Measures

Name	Time	Method
The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	1 year	the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post-procedure.; A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.

Secondary Outcome Measures

Name	Time	Method
The event rate of all death	5 years
The event rate of cardiac death	5 years
The event rate of myocardial infarction	5 years
The composite event rate of death or myocardial infarction	5 years
the composite event rate of cardiac death or myocardial infarction	5 years
The event rate of target-vessel revascularization	5 years
The event rate of target-lesion revascularization	5 years
The event rate of stroke	5 years
The event rate of stent thrombosis	5 years	According to Academic Research Consortium(ARC) criteria
The event rate of procedural success	3 days	Defined as achievement of a final diameter stenosis of \<30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.

Trial Locations

Locations (11)

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Kwangju Christian Hospital; 🇰🇷 Kwangju, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic Univ. of Korea Eunpyeong St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of

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