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

Ischemic Heart Disease Clinical Trial

— SMARTDESK-MX  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02986295
• Other study ID #: 2016-04-059
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2016
• Last updated: February 7, 2018
• Start date: April 1, 2016
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2018
• Source: Samsung Medical Center
• Contact: Hyeon Cheol Gwon
• Email: hc.gwon[@]samsung.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• BioMimeTM Stent, Ultimaster® Stent

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Hyeon-Cheol Gwon	Meril Life Sciences Pvt. Ltd., Terumo Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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). pii: e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817. — View Citation

Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté 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, Jüni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. Review. — View Citation

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. — View Citation

Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vázquez N, Valdés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of 30-day and 2-year target lesion failure		30-day and 2-year
Secondary	Incidence of 30-day, 1-year, and 2-year deaths		30-day, 1-year, and 2-year
Secondary	Incidence of 30-day, 1-year, and 2-year cardiac events		30-day, 1-year, and 2-year
Secondary	Incidence of 30-day, 1-year, and 2-year myocardial infarction		30-day, 1-year, and 2-year
Secondary	Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction		30-day, 1-year, and 2-year
Secondary	Incidence of 30-day, 1-year, and 2-year revascularization		30-day, 1-year, and 2-year
Secondary	Incidence of 30-day, 1-year, and 2-year target revascularization		30-day, 1-year, and 2-year
Secondary	Incidence of 30-day, 1-year, and 2-year stroke		30-day, 1-year, and 2-year
Secondary	Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years		24 hours, 30 days, 1 and 2 years