Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02845804
Status:
UNKNOWN
Last Update Posted:
2016-07-27
First Post:
2016-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1533}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2016-07-24', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '12 months', 'description': 'Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Target vessel failure', 'timeFrame': '12 months', 'description': 'Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)'}, {'measure': 'Composite rate of cardiac death and myocardial infarction', 'timeFrame': '12 months, 3 years'}, {'measure': 'Composite rate of all-cause death and any myocardial infarction', 'timeFrame': '12 months, 3 years'}, {'measure': 'Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization', 'timeFrame': '12 months, 3 years'}, {'measure': 'Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy', 'timeFrame': '12 months, 3 years'}, {'measure': 'Clinical device and procedural success rate', 'timeFrame': 'intraoperative'}, {'measure': 'Stent thrombosis', 'timeFrame': 'within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year', 'description': 'acute (within 24 hours), subacute (1 - 30 days), late (31 days - 1 year), very late (\\>1 year)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'percutaneous coronary intervention', 'everolimus-eluting stents'], 'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Acute Coronary Syndrome', 'Angina Pectoris']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are\n\n1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent\n2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent\n3. To compare the long-term efficacy and safety of coronary stenting between the Xience Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had established their own registry', 'detailedDescription': 'Secondary endpoints of this study are\n\nStent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI\n\nTarget vessl failure\n\nComposite rate of cardiac death and any MI, 3 years\n\nComposite rate of all death and any MI\n\nComposite rate of all death, any MI, and any repeat revascularization\n\nCompliance and therapy interruptions with prescribed adjunctive antiplatelet therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All coronary arterial disease patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent(s)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient agrees to participate in this study by signing the informed consent form.\n\nAlternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this registry."}, 'identificationModule': {'nctId': 'NCT02845804', 'acronym': 'HOST-ALPINE', 'briefTitle': 'Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions- Registry-based Study on the Effect and Safety of Xience Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Alpine Registry', 'orgStudyIdInfo': {'id': 'HOST-ALPINE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alpine', 'description': 'The patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™', 'interventionNames': ['Device: Alpine']}], 'interventions': [{'name': 'Alpine', 'type': 'DEVICE', 'otherNames': ['Everolimus-eluting stent'], 'armGroupLabels': ['Alpine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chuncheon', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yong-Hoon Kim', 'role': 'CONTACT'}, {'name': 'Yong-Hoon Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Wŏnju', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-Han Yoon', 'role': 'CONTACT'}, {'name': 'Jung-Han Yoon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Jin Choi', 'role': 'CONTACT'}, {'name': 'Young-Jin Choi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sejong General Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Anyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Ho Jo, MD,PhD', 'role': 'CONTACT'}, {'name': 'Sang-Ho Jo, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae-Hyun Yang', 'role': 'CONTACT'}], 'facility': 'Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong Ho Heo', 'role': 'CONTACT'}], 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheonan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byung-Eun Park, MD,PhD', 'role': 'CONTACT'}, {'name': 'Byung-Eun Park, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Cheonan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Ho Park', 'role': 'CONTACT'}, {'name': 'Sang-Ho Park', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SoonChunHyang University Cheonan Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-Sun Park, MD,PhD', 'role': 'CONTACT', 'email': 'pjs@medical.yu.ac.kr'}, {'name': 'Jong-Sun Park, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yongnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung-Ho Jeong', 'role': 'CONTACT'}], 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Iksan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seok-Kyo Oh, MD,PhD', 'role': 'CONTACT', 'email': 'oskcar@wonkwang.ac.kr'}, {'name': 'Seok-Kyo Oh, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Inchon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seong-Il Woo, MD,PhD', 'role': 'CONTACT', 'email': 'wjswgs@naver.com'}, {'name': 'Seong-Il Woo, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 35.55479, 'lon': 126.6251}}, {'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jang-Hwan Bae, MD,PhD', 'role': 'CONTACT', 'email': 'drcorazon@hanmail.net'}, {'name': 'Jang-Hwan Bae, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Je-Young Rhew, MD,PhD', 'role': 'CONTACT', 'email': 'jkrhew@hanafos.com'}, {'name': 'Je-Young Rhew, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In-Ho Chae, MD,PhD', 'role': 'CONTACT'}, {'name': 'In-Ho Chae, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki-Cheol Sung, MD,PhD', 'role': 'CONTACT'}, {'name': 'Ki-Cheol Sung, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Hyo Lim', 'role': 'CONTACT'}, {'name': 'Young-Hyo Lim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hanyang University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyoo-Rok Han, MD,PhD', 'role': 'CONTACT', 'email': 'krheart@hallym.or.kr'}, {'name': 'Kyoo-Rok Han, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Hyun Kim, MD,PhD', 'role': 'CONTACT', 'email': 'shkimmd@snu.ac.kr'}, {'name': 'Sang-Hyun Kim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul Boramae Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '+82-2-2072-2223'}, {'name': 'Hyo-soo Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bon-Kwon Koo, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyun-Jae Kang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jung-Kyu Han, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sang-Eun Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyo-soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '+82-2-2072-2226'}], 'overallOfficials': [{'name': 'Hyo-soo Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyo-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}