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

D

Duk-Woo Park, MD

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Drug: Ultimaster™ Tansei™ stents

Study type

Observational

Funder types

Other

Identifiers

NCT04443530
AMCCV2020-07

Details and patient eligibility

About

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

Enrollment

2,000 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

Coronary artery stenosis
Description:
Patients with coronary artery disease
Treatment:
Drug: Ultimaster™ Tansei™ stents

Trial contacts and locations

11

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Central trial contact

Jung-hee Ham, RN

Data sourced from clinicaltrials.gov

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