Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-01 @ 10:43 PM
Study NCT ID:
NCT02986295
Status:
UNKNOWN
Last Update Posted:
2018-02-09
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'C535731', 'term': 'Dysequilibrium syndrome'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-07', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of 1-year target lesion failure', 'timeFrame': '1-year', 'description': 'The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization).'}], 'secondaryOutcomes': [{'measure': 'Incidence of 30-day and 2-year target lesion failure', 'timeFrame': '30-day and 2-year'}, {'measure': 'Incidence of 30-day, 1-year, and 2-year deaths', 'timeFrame': '30-day, 1-year, and 2-year'}, {'measure': 'Incidence of 30-day, 1-year, and 2-year cardiac events', 'timeFrame': '30-day, 1-year, and 2-year'}, {'measure': 'Incidence of 30-day, 1-year, and 2-year myocardial infarction', 'timeFrame': '30-day, 1-year, and 2-year'}, {'measure': 'Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction', 'timeFrame': '30-day, 1-year, and 2-year'}, {'measure': 'Incidence of 30-day, 1-year, and 2-year revascularization', 'timeFrame': '30-day, 1-year, and 2-year'}, {'measure': 'Incidence of 30-day, 1-year, and 2-year target revascularization', 'timeFrame': '30-day, 1-year, and 2-year'}, {'measure': 'Incidence of 30-day, 1-year, and 2-year stroke', 'timeFrame': '30-day, 1-year, and 2-year'}, {'measure': 'Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years', 'timeFrame': '24 hours, 30 days, 1 and 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BioMime, Ultimaster, Ischemic heart disease, DES'], 'conditions': ['Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '18430909', 'type': 'BACKGROUND', '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.'}, {'pmid': '17145250', 'type': 'BACKGROUND', 'citation': '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': '17869634', 'type': 'BACKGROUND', 'citation': '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': '26196753', 'type': 'BACKGROUND', 'citation': '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': '26446596', 'type': 'BACKGROUND', '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):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817.'}, {'pmid': '24459196', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ischemic heart disease with percutaneous coronary intervention with stenting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 19 years old or older\n2. 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).\n3. 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)\n4. Voluntary written consent to participate in the trial\n\nExclusion Criteria:\n\n1. Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock\n2. Life expectancy within 2 years'}, 'identificationModule': {'nctId': 'NCT02986295', 'acronym': 'SMARTDESK-MX', 'briefTitle': 'Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '2016-04-059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BioMimeTM Stent', 'description': 'No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent', 'interventionNames': ['Device: BioMimeTM Stent, Ultimaster® Stent']}, {'label': 'Ultimaster® Stent', 'description': 'No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent', 'interventionNames': ['Device: BioMimeTM Stent, Ultimaster® Stent']}], 'interventions': [{'name': 'BioMimeTM Stent, Ultimaster® Stent', 'type': 'DEVICE', 'armGroupLabels': ['BioMimeTM Stent', 'Ultimaster® Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyoen-Cheol Gwon, PhD', 'role': 'CONTACT', 'email': 'hc.gwon@samsung.com', 'phone': '82-2-3410-3418'}, {'name': 'Hyoen-Cheol Gwon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyeon Cheol Gwon', 'role': 'CONTACT', 'email': 'hc.gwon@samsung.com'}, {'name': 'Taek Kyu Park', 'role': 'CONTACT', 'email': 'taekkyu.park@samsung.com'}], 'overallOfficials': [{'name': 'Hyeon Cheol Gwon', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyeon-Cheol Gwon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Meril Life Sciences Pvt. Ltd.', 'class': 'INDUSTRY'}, {'name': 'Terumo Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyeon-Cheol Gwon', 'investigatorAffiliation': 'Samsung Medical Center'}}}}