Clinical trial NCT04443530: Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice
Official title: Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Tansei
Ultimaster
Ultimaster Tansei
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2020-06-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Ultimaster™ Tansei™ stents.

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


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

Primary outcomes:
measure: The composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
timeFrame: 1 year
Secondary outcomes:
measure: The event rate of all death
timeFrame: 5 years
measure: The event rate of cardiac death
timeFrame: 5 years
measure: The event rate of myocardial infarction
timeFrame: 5 years
measure: The composite event rate of death or myocardial infarction
timeFrame: 5 years
measure: the composite event rate of cardiac death or myocardial infarction
timeFrame: 5 years
measure: The event rate of target-vessel revascularization
timeFrame: 5 years
measure: The event rate of target-lesion revascularization
timeFrame: 5 years
measure: The event rate of stent thrombosis
timeFrame: 5 years
measure: The event rate of stroke
timeFrame: 5 years
measure: The event rate of procedural success
timeFrame: 3 days
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
city: Suncheon
country: Korea, Republic of
facility: St.Carollo Hospital
Study officials:
References: