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

Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Ultimaster™ Tansei™ stents

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Jung-hee Ham, RN; Phone Number: 82230104728; Email: cvcrc5@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Recruiting
    • Gangwon National Univ. Hospital
    • Contact: Bong-ki Lee, MD
    • Principal Investigator: Bong-Ki Lee, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Hyuck-joon Yoon, MD
    • Principal Investigator: Hyuck-joon Yoon, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Daegu Catholic University Medical Center
    • Principal Investigator: Jin-bae Lee, MD
    • Contact: Jin-bae Lee, MD
  • Daejeon, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
    • Contact: Man-won Park, MD
    • Principal Investigator: Man-won Park, MD
  • Gangneung, Korea, Republic of
    • Recruiting
    • GangNeung Asan Hospital
    • Contact: Han-bit Park, MD
    • Principal Investigator: Han-bit Park, MD
  • Kwangju, Korea, Republic of
    • Recruiting
    • Kwangju Christian hospital
    • Contact: Seung-uk Lee, MD
    • Principal Investigator: Seung-uk Lee, MD
  • Pusan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
    • Contact: Han-cheol Lee, MD
    • Principal Investigator: Han-cheol Lee, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Duk-woo Park, MD; Email: dwpark@amc.seoul.kr
    • Principal Investigator: Duk-woo Park, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangdong Sacred Heart Hospital
    • Contact: Won-woo Seo, MD
    • Principal Investigator: Won-woo Seo, MD
  • Seoul, Korea, Republic of
    • Withdrawn
    • The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
  • Suncheon, Korea, Republic of
    • Recruiting
    • St.carollo Hospital
    • Contact: Jang-Hyun Cho, MD
    • Principal Investigator: Jang-Hyun Cho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Ultimaster™ Tansei™ stents.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary artery stenosis; Patients with coronary artery disease	Drug: Ultimaster™ Tansei™ stents; Patients receiving Ultimaster™ Tansei™ stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 event rate of target-vessel revascularization		5 years
The event rate of target-lesion revascularization		5 years
The event rate of stent thrombosis	According to Academic Research Consortium(ARC) criteria	5 years
The event rate of stroke		5 years
The event rate of procedural success	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.	3 days
the composite event rate of cardiac death or myocardial infarction		5 years

Collaborators and Investigators

• Sponsor: Duk-Woo Park, MD
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Tansei; Ultimaster; Ultimaster Tansei
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: AMCCV2020-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No