Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT02760732
Status:
UNKNOWN
Last Update Posted:
2017-11-30
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Eluting Balloon for Treatment of Unstable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2016-04-30', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Target Lumen assessed by optical coherence tomography', 'timeFrame': '12 months', 'description': 'A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.'}], 'secondaryOutcomes': [{'measure': 'Incidence rate of MACE', 'timeFrame': 'Incidence rate of MACE from baseline to 12 months', 'description': 'MACE include composite of death, myocardial infarction, or target-vessel revascularization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Angina, Unstable']}, 'referencesModule': {'references': [{'pmid': '27846629', 'type': 'DERIVED', 'citation': 'Li B, Ding Y, Tian F, Chen W, Han T, Chen Y. Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial. Cardiology. 2017;136(4):252-257. doi: 10.1159/000452125. Epub 2016 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.', 'detailedDescription': 'Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18, \\< 80 years old, with unstable angina\n* Single-vessel or double-vessel disease\n* Length of target lesion \\< 25mm\n* Diameter of target vessel \\>2.5mm, \\< 3.5mm\n\nExclusion Criteria:\n\n* Left main disease\n* Chronic total occlusion\n* Severe Tortuosity\n* Heavy calcification\n* Severe liver failure, moderate or severe kidney failure\n* Malignant disease\n* Active infectious disease\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02760732', 'briefTitle': 'Drug Eluting Balloon for Treatment of Unstable Angina', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina', 'orgStudyIdInfo': {'id': '301_xnk1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'drug eluting balloon group', 'description': 'patients with unstable angina were randomised to drug eluting balloon group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon(Flextome Cutting Balloon, Boston Scientific Corporation, US) pre-dilation first and then drug eluting balloon(Sequent please; B. Braun, Melsungen, Germany) .', 'interventionNames': ['Device: drug eluting balloon; cutting balloon']}, {'type': 'EXPERIMENTAL', 'label': 'drug eluting stent group', 'description': 'patients with unstable angina were randomised to this group for drug eluting stent (YINYI® Polymer-free Drug-coated (Paclitaxel) Coronary Stent System, Liaoning Biomedical Materials R\\&D Center Co., Ltd. China) implantation.', 'interventionNames': ['Device: drug eluting stent']}], 'interventions': [{'name': 'drug eluting balloon; cutting balloon', 'type': 'DEVICE', 'otherNames': ['Sequent please; B. Braun; Flextome Cutting Balloon, Boston Scientific'], 'description': 'Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.', 'armGroupLabels': ['drug eluting balloon group']}, {'name': 'drug eluting stent', 'type': 'DEVICE', 'otherNames': ['YINYI®'], 'description': 'with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.', 'armGroupLabels': ['drug eluting stent group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LI BO, MD', 'role': 'CONTACT', 'email': '22401919@QQ.COM', 'phone': '+8601055499309'}], 'facility': 'The General Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'LI BO, MD', 'role': 'CONTACT', 'email': '22401919@qq.com', 'phone': '+8601055499309'}], 'overallOfficials': [{'name': 'CHEN YUN DAI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The General Hospital of PLA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yun Dai Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yun Dai Chen', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}