Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-01 @ 3:05 AM
Study NCT ID:
NCT01066832
Status:
COMPLETED
Last Update Posted:
2011-06-17
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Valentines Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-16', 'studyFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis', 'timeFrame': '6-9 month'}], 'secondaryOutcomes': [{'measure': 'In-stent and in-segment late loss and binary restenosis', 'timeFrame': '6-9 month'}]}, 'conditionsModule': {'keywords': ['Drug-eluting balloon', 'Paclitaxel', 'DIOR', 'short term registry', 'Valentines Trial', 'Drug-eluting balloon treatment of in-stent restenosis'], 'conditions': ['Instent Restenosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction \\[MI\\], target lesion revascularization \\[TLR\\]) and target vessel revascularization \\[TVR\\]) and stent thrombosis, both early and late occurrences will be assessed.\n\nIn addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis.\n\nA prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, male or female, \\> 18 years of age;\n* Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;\n* The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);\n* The target lesion is in a native vessel;\n* Up to two lesions per patient;\n* Target lesion(s) stenosis is \\> 50%.\n\nExclusion Criteria:\n\n* The patient has had an acute myocardial infarction within the last 48 hours;\n* The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to \\<12 months);\n* Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);\n* The patient has had previous therapeutic radiation to the target vessel;\n* The patient is unable the take dual antiplatelet therapy for at least 6 months;\n* Patients with three or more lesions with in-stent restenosis requiring angioplasty.'}, 'identificationModule': {'nctId': 'NCT01066832', 'briefTitle': 'The Valentines Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eurocor GmbH'}, 'officialTitle': 'The Valentines Trial', 'orgStudyIdInfo': {'id': 'Eur-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel-coated balloon (3 µg/mm2)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'country': 'Germany', 'facility': 'Heart Center Munich at the Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'Policlinico', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Pieter Stella, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht, Utrecht, Netherlands'}, {'name': 'Sigmund Silber, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Munich at the Isar, Munich, Germany'}, {'name': 'Giuseppe Sangiorgi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Modena, Modena, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurocor GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Rembert Pogge von Strandmann', 'oldOrganization': 'Eurocor GmbH'}}}}