Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:49 PM
Study NCT ID:
NCT01084408
Status:
TERMINATED
Last Update Posted:
2021-03-25
First Post:
2010-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'whyStopped': 'no suitable patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late lumen loss', 'timeFrame': '6 months', 'description': 'Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.'}], 'secondaryOutcomes': [{'measure': 'Thrombotic occlusion of the target lesion', 'timeFrame': '30 days, 6, 12, 24, 60 months'}, {'measure': 'Revascularization of the target lesion', 'timeFrame': '30 days, 6, 12, 24, 60 months'}, {'measure': 'Myocardial infarction', 'timeFrame': '30 days, 6, 12, 24, 60 months'}, {'measure': 'Death', 'timeFrame': '30 days, 6, 12, 24, 60 months'}, {'measure': 'Combined clinical endpoint (MACE)', 'timeFrame': '30 days, 6, 12, 24, 60 months', 'description': 'consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['de-novo', 'coronary stenoses', 'PEPCAD', 'DEBonly', 'Paclitaxel'], 'conditions': ['Coronary De-novo Stenoses']}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* Clinical evidence of stable or unstable angina or a positive functional study\n* Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)\n* Diameter stenosis \\> 70% (visual estimate)\n* Vessel diameter 2.5 - 3.5 mm\n* Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization\n* Signed patient informed consent form\n* Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol\n\nExclusion Criteria:\n\n* Left ventricular ejection fraction of \\< 30%\n* Visible thrombus proximal to the lesion\n* Expection that treatment with devices other than PTCA will be required for this lesion.\n* Stenosis is within a bypass graft\n* Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated\n* Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).\n* Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) \\>3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)\n* Chronic renal insufficiency with serum creatinine \\> 2.0 mg%\n* Significant gastrointestinal (GI) bleed within the past six months.\n* History of bleeding diathesis or coagulopathy or will refuse blood transfusions\n* Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.\n* Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study"}, 'identificationModule': {'nctId': 'NCT01084408', 'acronym': 'PEPCAD-DEBonly', 'briefTitle': 'Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon', 'orgStudyIdInfo': {'id': 'Pac 14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequent®Please', 'interventionNames': ['Device: SeQuent®Please (Paclitaxel coated balloon)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Taxus™Liberté™', 'interventionNames': ['Device: Taxus™Liberté™ (Paclitaxel eluting stent)']}], 'interventions': [{'name': 'SeQuent®Please (Paclitaxel coated balloon)', 'type': 'DEVICE', 'description': 'PCI of de-novo lesions', 'armGroupLabels': ['Sequent®Please']}, {'name': 'Taxus™Liberté™ (Paclitaxel eluting stent)', 'type': 'DEVICE', 'description': 'PCI of de-novo lesions', 'armGroupLabels': ['Taxus™Liberté™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14467', 'city': 'Postdam', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann'}, {'zip': '22527', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Medizinisches Versorgungszentrum', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Bruno Scheller, Prof. Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uniklinikum des Saarlandes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bruno Scheller', 'investigatorAffiliation': 'University Hospital, Saarland'}}}}