Ischemic Heart DiseaseSMARTDESK-MXNCT02986295
Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent
An observational study of Ischemic Heart Disease, run by Hyeon-Cheol Gwon at 1 site in South Korea.
Trial summary
Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- BioMimeTM Stent, Ultimaster® Stent
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2016to 31 Jan 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic heart disease with percutaneous coronary intervention with stenting
Who may be able to join
- 19 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
Who cannot join
- Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock
- Life expectancy within 2 years
Trial locations and contacts
1 site in 1 country.
Hyeon Cheol Gwon contact
Taek Kyu Park contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Hyoen-Cheol Gwon, PhD, 82-2-3410-3418, hc.gwon@samsung.com
Hyoen-Cheol Gwon, PhD
About this study
Official title: 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
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.
- Conditions
- Ischemic Heart Disease
- Being tested
- BioMimeTM Stent, Ultimaster® Stent
- Keywords
- BioMime, Ultimaster, Ischemic heart disease, DES
- Medical subject headings
- Myocardial Ischemia, Dysequilibrium syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMimeTM Stent, Ultimaster® StentDevice
| Study group | Role | What they receive |
|---|---|---|
| BioMimeTM Stent | No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent Receives: Device: BioMimeTM Stent, Ultimaster® Stent | |
| Ultimaster® Stent | No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent Receives: Device: BioMimeTM Stent, Ultimaster® Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-year
Secondary outcomes (9)
Incidence of 30-day and 2-year target lesion failure
Measured: 30-day and 2-year
Incidence of 30-day, 1-year, and 2-year deaths
Measured: 30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year cardiac events
Measured: 30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year myocardial infarction
Measured: 30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction
Measured: 30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year revascularization
Measured: 30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year target revascularization
Measured: 30-day, 1-year, and 2-year
Incidence of 30-day, 1-year, and 2-year stroke
Measured: 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
Measured: 24 hours, 30 days, 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 Apr 2016
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hyeon-Cheol Gwon
- Sponsor type
- University, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd., Terumo Corporation
- Responsible party
- Sponsor-investigator, Hyeon-Cheol Gwon, Samsung Medical Center
- Investigators
- Hyeon Cheol Gwon, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986295
- Sponsor's protocol ID
- 2016-04-059
- Acronym
- SMARTDESK-MX
- Status last verified
- Feb 2018
- First submitted
- 6 Dec 2016
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 18430909Bavry 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 17145250Stettler 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 17869634Vlachojannis 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 26196753Natsuaki 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 26446596Kang 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02986295
- Acronym / sponsor ID
- SMARTDESK-MX / 2016-04-059
- Conditions
- Ischemic Heart Disease
- Keywords
- BioMime, Ultimaster, Ischemic heart disease, DES
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hyeon-Cheol GwonUniversity, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd., Terumo Corporation
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioMimeTM Stent | – | Device: BioMimeTM Stent, Ultimaster® StentNo intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent |
| Ultimaster® Stent | – | Device: BioMimeTM Stent, Ultimaster® StentNo intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic heart disease with percutaneous coronary intervention with stenting
Key inclusion criteria (4 listed)
- 19 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
Key exclusion criteria (2 listed)
- Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock
- Life expectancy within 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMimeTM Stent, Ultimaster® Stent | Device | BioMimeTM Stent, Ultimaster® Stent |
Primary outcome
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).
9 secondary outcomes
Incidence of 30-day and 2-year target lesion failure
Time frame: 30-day and 2-year
Incidence of 30-day, 1-year, and 2-year deaths
Time frame: 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
Incidence of 30-day, 1-year, and 2-year myocardial infarction
Time frame: 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
Incidence of 30-day, 1-year, and 2-year revascularization
Time frame: 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
Incidence of 30-day, 1-year, and 2-year stroke
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Background: PubMed 18430909Stone 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.
- Background: PubMed 17145250Bavry 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.
- Background: PubMed 17869634Stettler 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.
- Background: PubMed 26196753Vlachojannis 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.
- Background: PubMed 26446596Natsuaki 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.
- Background: PubMed 24459196Kang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeon Cheol Gwon contact
Taek Kyu Park contact
Hyeon Cheol Gwon study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Hyeon-Cheol Gwon at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyeon Cheol Gwon (hc.gwon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of 1-year target lesion failure (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986295, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.