NCT02986295

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

December 6, 2016

Last Update Submit

February 7, 2018

Conditions

Ischemic Heart Disease

Keywords

BioMime, Ultimaster, Ischemic heart disease, DES

Outcome Measures

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).

    1-year

Secondary Outcomes (9)

  • Incidence of 30-day and 2-year target lesion failure

    30-day and 2-year

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

    30-day, 1-year, and 2-year

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

    30-day, 1-year, and 2-year

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

    30-day, 1-year, and 2-year

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

    30-day, 1-year, and 2-year

  • +4 more secondary outcomes

Study Arms (2)

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

BioMimeTM Stent, Ultimaster® StentDEVICE
BioMimeTM StentUltimaster® Stent

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ischemic heart disease with percutaneous coronary intervention with stenting

You may qualify if:

  • years old or older
  • 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).
  • 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)
  • Voluntary written consent to participate in the trial

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Related Publications (6)

  • 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.

    PMID: 18430909BACKGROUND

  • 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.

    PMID: 17145250BACKGROUND

  • 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.

    PMID: 17869634BACKGROUND

  • 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.

    PMID: 26196753BACKGROUND

  • 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.

    PMID: 26446596BACKGROUND

  • 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.

    PMID: 24459196BACKGROUND

MeSH Terms

Conditions

Myocardial IschemiaDysequilibrium syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Hyeon Cheol Gwon

    Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Hyeon Cheol Gwon

CONTACT

hc.gwon@samsung.com

Taek Kyu Park

CONTACT

taekkyu.park@samsung.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 8, 2016

Study Start

April 1, 2016

Primary Completion

January 31, 2019

Study Completion

January 31, 2021

Last Updated

February 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)