Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-30 @ 10:10 PM
Study NCT ID:
NCT01903902
Status:
UNKNOWN
Last Update Posted:
2013-07-19
First Post:
2013-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-18', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late loss', 'timeFrame': '9±1 months', 'description': 'Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary'}, {'measure': 'Binary restenosis rate', 'timeFrame': '9±1 months', 'description': 'Restenosis rate of the target lesion at the follow-up quantitative coronary angiography'}], 'secondaryOutcomes': [{'measure': 'Neointimal hyperplasia', 'timeFrame': '9±1 months', 'description': 'Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam'}, {'measure': 'Clinical outcomes', 'timeFrame': '9±1 months', 'description': 'Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Balloon angioplasty', 'Drug-eluting balloon'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.', 'detailedDescription': 'Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis.\n\nDEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.\n\nThe purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 19 years\n* Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length \\< 25 mm)\n* Informed consent\n\nExclusion Criteria:\n\n* Chronic total obstruction lesion\n* Severe calcified lesion\n* Left main coronary lesion\n* Lesion having intravascular thrombus\n* Shock status from any cause including cardiogenic shock\n* Left ventricular ejection fraction \\< 30%\n* Need for coronary artery bypass surgery\n* Allergic reaction for paclitaxel\n* Severe allergic for contrast agent (Visipaque) or statin\n* Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age'}, 'identificationModule': {'nctId': 'NCT01903902', 'briefTitle': 'Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)', 'orgStudyIdInfo': {'id': 'DEB-ONLY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-eluting balloon', 'description': 'Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter \\> 2.25 mm and ≤ 2.75 mm)', 'interventionNames': ['Device: SeQuent® Please Drug-eluting balloon']}], 'interventions': [{'name': 'SeQuent® Please Drug-eluting balloon', 'type': 'DEVICE', 'description': 'Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length \\< 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.', 'armGroupLabels': ['Drug-eluting balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '405-760', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woong Chul Kang, M.D.', 'role': 'CONTACT', 'email': 'kangwch@gilhospital.com', 'phone': '+82-32-460-3663'}, {'name': 'Woong Chul Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Woong Chul Kang, M.D.', 'role': 'CONTACT', 'email': 'kangwch@gilhospital.com', 'phone': '+82-32-460-3663'}], 'overallOfficials': [{'name': 'Woong Chul Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, {'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'Jeju National University Hospital', 'class': 'OTHER'}, {'name': 'Daegu Catholic University Medical Center', 'class': 'OTHER'}, {'name': 'Chungbuk National University', 'class': 'OTHER'}, {'name': 'Dankook University', 'class': 'OTHER'}, {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, {'name': 'Kwandong University Myongji Hospital', 'class': 'UNKNOWN'}, {'name': 'Kosin University Gospel Hospital', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, {'name': 'National Health Insurance Service Ilsan Hospital', 'class': 'OTHER'}, {'name': 'Saint Carollo General Hospital', 'class': 'UNKNOWN'}, {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, {'name': 'Sejong General Hospital', 'class': 'OTHER'}, {'name': 'Cheju Halla General Hospital', 'class': 'OTHER'}, {'name': 'Wonkwang University', 'class': 'OTHER'}, {'name': 'Konyang University Hospital', 'class': 'OTHER'}, {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Woong Chol Kang', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}