Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02932995
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DXR Stent for Vascular Healing and Thrombus Formation: OCT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-18', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)', 'timeFrame': '1 year', 'description': 'Clinical outcome follow up'}, {'measure': 'long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)', 'timeFrame': '3 year', 'description': 'Clinical outcome follow up'}], 'primaryOutcomes': [{'measure': 'Stent strut coverage (Incidence of uncovered strut)', 'timeFrame': '6 month', 'description': 'Coronary angiography with OCT follow up'}], 'secondaryOutcomes': [{'measure': 'Stent malapposition', 'timeFrame': '6 month', 'description': 'Coronary angiography with OCT follow up'}, {'measure': 'Stent thrombosis', 'timeFrame': '6 month', 'description': 'Coronary angiography with OCT follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Optical Coherence Tomography', 'Drug-Eluting Stent'], 'conditions': ['Coronary Artery Disease', 'Coronary Stent Occlusion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage, malapposition, and thrombus formation, assessed by an optical coherence tomography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo coronary artery intervention with DXR stent', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient\n\n * Age \\>=19 years\n * Clinically indicated to invasive coronary angiography\n * Patient capable and willing of giving written informed consent\n2. Angiographic\n\n * coronary artery disease confined to native coronary artery\n * \\>50% diameter stenosis by invasive coronary angiography\n * reference diameter 2.5-4.0mm, lesion length ≤30 mm\n\nExclusion Criteria:\n\n1. Patient\n\n * Inability to provide written informed consent\n * Serious comorbidity which may affect the trial by decision of investigators\n * Prior CABG to target vessel\n * Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30%\n * Prior ST elevation myocardial infarction within 72 hours from the procedure\n * Hemodynamic or electrical instability including shock\n * Serious coronary artery spasm, unrelated to catheter\n * Pregnancy or possible pregnant status\n * Allergy to iodinated contrast agent\n * Serum creatinine \\>=1.7 mg/dL or creatinine clearance \\<= 30 ml/min\n * ST elevation myocardial infarction\n2. Angiographic (OCT)\n\n * Left main disease\n * Severely calcified lesion\n * Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision"}, 'identificationModule': {'nctId': 'NCT02932995', 'briefTitle': 'DXR Stent for Vascular Healing and Thrombus Formation: OCT Study', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University'}, 'officialTitle': 'Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study', 'orgStudyIdInfo': {'id': 'C2015201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DXR stent group', 'description': 'Patients who undergo coronary intervention with DXR stent'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35365', 'city': 'Daejeon', 'country': 'South Korea', 'contacts': [{'name': 'Jangho Bae', 'role': 'CONTACT', 'email': 'janghobae@yahoo.co.kr', 'phone': '+82-42-600-9409'}, {'name': 'Jangho Bae, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Jeju City', 'country': 'South Korea', 'facility': 'Jeju National University Hospital', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}, {'zip': '02447', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'JIN WON KIM', 'role': 'CONTACT', 'email': 'kjwmm@korea.ac.kr', 'phone': '+82-2-2626-1899'}, {'name': 'JIN WON KIM, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'contacts': [{'name': 'Eun Seok Shin', 'role': 'CONTACT', 'email': 'sesim1989@gmail.com', 'phone': '+82-52-250-8838'}, {'name': 'Eun Seok Shin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ulsan university hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'centralContacts': [{'name': 'Sang-Wook Kim, MD, PhD', 'role': 'CONTACT', 'email': 'swivus@gmail.com', 'phone': '+82-6299-1260'}], 'overallOfficials': [{'name': 'Sang-Wook Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Konyang University Hospital', 'class': 'OTHER'}, {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'Jeju National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang-Wook Kim', 'investigatorAffiliation': 'Chung-Ang University'}}}}