Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-05 @ 8:00 PM
Study NCT ID:
NCT01899235
Status:
TERMINATED
Last Update Posted:
2014-03-18
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], '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'}, {'id': 'D003327', 'term': 'Coronary Disease'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-15', 'studyFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2013-07-12', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stable Angina', 'Coronary Stenosis']}, 'descriptionModule': {'briefSummary': 'A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 18years old\n* Stable angina symptoms\n* Elective treatment to coronary lesion\n* Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection\n\nExclusion Criteria:\n\n* Left main stem lesion\n* Bifurcation lesions\n* Acute coronary syndrome (UAP, NSTEMI, STEMI)\n* Cardiogenic shock\n* Chronic total occlusion\n* Additional lesions requiring PCI\n* Platelet count ≤ 50 x 109/mm3\n* Left ventricular ejection fraction ≤ 30%\n* Patient life expectancy less than 12 months\n* Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel\n* Participation in another investigational drug or device study\n* Patient unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01899235', 'acronym': 'EXPEL', 'briefTitle': 'The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study', 'orgStudyIdInfo': {'id': 'N-20110015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stent', 'description': 'drug eluting stent (Resolute)', 'interventionNames': ['Device: drug eluting stent']}, {'type': 'EXPERIMENTAL', 'label': 'drug eluting balloon', 'description': 'drug eluting balloon (Elutax)', 'interventionNames': ['Device: drug eluting balloon']}], 'interventions': [{'name': 'drug eluting balloon', 'type': 'DEVICE', 'armGroupLabels': ['drug eluting balloon']}, {'name': 'drug eluting stent', 'type': 'DEVICE', 'armGroupLabels': ['Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aachen Resonance GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, MD, PhD', 'investigatorFullName': 'Svend Eggert Jensen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}