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

NCT04443530 | Recruiting

• 1 other identifier: AMCCV2020-07
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Tansei; Ultimaster; Ultimaster Tansei

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (1)

Coronary artery stenosis

Patients with coronary artery disease

Drug: Ultimaster™ Tansei™ stents

Interventions

Ultimaster™ Tansei™ stents DRUG

Patients receiving Ultimaster™ Tansei™ stents

Coronary artery stenosis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Ultimaster™ Tansei™ stents.

You may qualify if:

• Patients ≥ 19 years old
• Patients receiving Ultimaster™ Tansei™ stents.
• 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.

You may not qualify if:

• Patients with a mixture of other drug-eluting stents (DESs)
• Terminal illness with life-expectancy ≤1 year.
• Patients with cardiogenic shock

Sponsors & Collaborators

• Duk-Woo Park, MD: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (11)

Gangwon National Univ. Hospital

Chuncheon, South Korea

RECRUITING

Daegu Catholic University Medical Center

Daegu, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

RECRUITING

Gangneung Asan Hospital

Gangneung, South Korea

RECRUITING

Kwangju Christian Hospital

Kwangju, South Korea

RECRUITING

Pusan National University Hospital

Pusan, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

Seoul, South Korea

WITHDRAWN

St.Carollo Hospital

Suncheon, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jung-hee Ham, RN

CONTACT

82230104728; cvcrc5@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 23, 2020
• Study Start: September 17, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

KR (11)