CClinicalTrials.gg
Status unknownNCT02986295SMARTDESK-MXUpdated Feb 9, 2018

Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent

An observational study in Ischemic Heart Disease, sponsored by Hyeon-Cheol Gwon. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-02-09.

Sponsored by Hyeon-Cheol Gwon · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
19 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Ischemic Heart Disease

Keywords

  • BioMime, Ultimaster, Ischemic heart disease, DES
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Hyeon-Cheol Gwon is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Ischemic heart disease with percutaneous coronary intervention with stenting

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • DeviceBioMimeTM Stent, Ultimaster® Stent
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What researchers measure

Primary outcomes

  1. The incidence of 1-year target lesion failure

    The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization).

    Time frame: 1-year

Secondary outcomes

  1. Incidence of 30-day and 2-year target lesion failure

    Time frame: 30-day and 2-year

  2. Incidence of 30-day, 1-year, and 2-year deaths

    Time frame: 30-day, 1-year, and 2-year

  3. Incidence of 30-day, 1-year, and 2-year cardiac events

    Time frame: 30-day, 1-year, and 2-year

  4. Incidence of 30-day, 1-year, and 2-year myocardial infarction

    Time frame: 30-day, 1-year, and 2-year

  5. Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction

    Time frame: 30-day, 1-year, and 2-year

  6. Incidence of 30-day, 1-year, and 2-year revascularization

    Time frame: 30-day, 1-year, and 2-year

  7. Incidence of 30-day, 1-year, and 2-year target revascularization

    Time frame: 30-day, 1-year, and 2-year

  8. Incidence of 30-day, 1-year, and 2-year stroke

    Time frame: 30-day, 1-year, and 2-year

  9. 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

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Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
    • Hyoen-Cheol Gwon, PhD · Contact · hc.gwon@samsung.com · 82-2-3410-3418
    • Hyoen-Cheol Gwon, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903. PubMed 18430909 ↗
  • Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023. PubMed 17145250 ↗
  • Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5. PubMed 17869634 ↗
  • Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53. PubMed 26196753 ↗
  • Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817. PubMed 26446596 ↗
  • Kang SH, Park KW, Kang DY, Lim WH, Park KT, Han JK, Kang HJ, Koo BK, Oh BH, Park YB, Kandzari DE, Cohen DJ, Hwang SS, Kim HS. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014 May;35(17):1147-58. doi: 10.1093/eurheartj/eht570. Epub 2014 Jan 23. PubMed 24459196 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02986295
Lead sponsor
Hyeon-Cheol Gwon
Collaborators
Meril Life Sciences Pvt. Ltd., Terumo Corporation
Responsible party
Hyeon-Cheol Gwon (Professor, Samsung Medical Center) — Sponsor-investigator
First posted
Dec 8, 2016
Start date
Apr 1, 2016
Primary completion
Jan 31, 2019 (estimated)
Completion
Jan 31, 2021 (estimated)
Last update
Feb 9, 2018

Study contacts

Hyeon Cheol Gwon
Contact
hc.gwon@samsung.com
Taek Kyu Park
Contact
taekkyu.park@samsung.com
Hyeon Cheol Gwon
study chair · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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