Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent (SMARTDESK-MX)

February 7, 2018 updated by: Hyeon-Cheol Gwon

Real World Drug-Eluting Stent Prospective, Open, Multi-site, Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent By SMart Angioplastry Research Team (SMARTDESK-MX)

Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective, open, multicenter, and observational study will register and compare Xience® groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively registered from June 2016.

The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Hyoen-Cheol Gwon, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ischemic heart disease with percutaneous coronary intervention with stenting

Description

Inclusion Criteria:

  1. 19 years old or older
  2. Clinical evidence of coronary artery disease including asymptomatic ischemia, stable angina pectoris, acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction).
  3. Vessel diameter 2.25 ~ 3.5mm, stenosis more than 50% (However, the number of blood vessels, the number of lesions, and the lesion length are not limited)
  4. Voluntary written consent to participate in the trial

Exclusion Criteria:

  1. Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock
  2. Life expectancy within 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BioMimeTM Stent
No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent
Device: BioMimeTM Stent, Ultimaster® Stent
Ultimaster® Stent
No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent
Device: BioMimeTM Stent, Ultimaster® Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of 1-year target lesion failure
Time Frame: 1-year
The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization).
1-year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of 30-day and 2-year target lesion failure
Time Frame: 30-day and 2-year
30-day and 2-year
Incidence of 30-day, 1-year, and 2-year deaths
Time Frame: 30-day, 1-year, and 2-year
30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year cardiac events
Time Frame: 30-day, 1-year, and 2-year
30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year myocardial infarction
Time Frame: 30-day, 1-year, and 2-year
30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction
Time Frame: 30-day, 1-year, and 2-year
30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year revascularization
Time Frame: 30-day, 1-year, and 2-year
30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year target revascularization
Time Frame: 30-day, 1-year, and 2-year
30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year stroke
Time Frame: 30-day, 1-year, and 2-year
30-day, 1-year, and 2-year
Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years
Time Frame: 24 hours, 30 days, 1 and 2 years
24 hours, 30 days, 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyeon-Cheol Gwon

Collaborators

Terumo Corporation
Meril Life Sciences Pvt. Ltd.

Investigators

  • Study Chair: Hyeon Cheol Gwon, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Anticipated)

January 31, 2019

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-04-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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