Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-29 @ 1:44 PM
Study NCT ID:
NCT03487432
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2018-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent expansion index (SEI)', 'timeFrame': 'intraprocedural', 'description': 'Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis'}], 'secondaryOutcomes': [{'measure': 'Angiographic Success', 'timeFrame': 'intraprocedural', 'description': "'Angiographic Success', defined as the achievement of residual angiographic stenosis \\<30% of the target lesion in the presence of TIMI 3 flow"}, {'measure': 'Procedural Success', 'timeFrame': '30 days', 'description': "'Procedural Success', defined as the achievement of angiographic success without any MACE, defined as cardiac death, target vessel related myocardial infarction and repeat revascularization (PTCA/PCI or coronary artery bypass graft \\[CABG\\])"}, {'measure': 'Strategy Success', 'timeFrame': 'intraprocedural', 'description': "'Strategy Success' defined as procedural success using the assigned study device and stent, without requirement for lesion preparations with further devices (i.e. rotational atherectomy \\[RA\\])"}, {'measure': 'Acute lumen gain,', 'timeFrame': 'intraprocedural', 'description': 'Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)'}, {'measure': 'Complementary lesion preparations', 'timeFrame': 'intraprocedural', 'description': 'Number of complementary lesion preparations with further devices (i.e. rotational atherectomy \\[RA\\])'}, {'measure': 'Rate of vessel perforation', 'timeFrame': 'intraprocedural', 'description': 'Rate of vessel perforation'}, {'measure': 'Procedure duration', 'timeFrame': 'intraprocedural', 'description': 'Procedure duration in min'}, {'measure': 'Contrast volume', 'timeFrame': 'intraprocedural', 'description': 'Contrast volume in mL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Calcified Coronary Artery Disease (Grade 3)']}, 'descriptionModule': {'briefSummary': 'The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years and consentable;\n* Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;\n* Angiographically-proven coronary artery disease;\n* De novo lesion in a native coronary artery;\n* Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;\n* Calcification of the target lesion as determined by angiography (grade 3);\n* Unsuccessful lesion preparation (\\<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty\n* Written informed consent.\n\nExclusion Criteria:\n\n* Myocardial infarction (within 1 week);\n* Limited long-term prognosis due to other conditions;\n* Target lesion is in a coronary artery bypass graft;\n* Target lesion is an in-stent restenosis;\n* Target lesion is aorto-ostial;\n* Target vessel thrombus.'}, 'identificationModule': {'nctId': 'NCT03487432', 'acronym': 'ISAR-CALC', 'briefTitle': 'A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions', 'orgStudyIdInfo': {'id': 'GE IDE Nr. BA00117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPN NC', 'description': 'Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)', 'interventionNames': ['Device: Super High-Pressure NC PTCA Balloon (OPN NC)']}, {'type': 'EXPERIMENTAL', 'label': 'NSE Alpha', 'description': 'Patients receiving a Scoring PTCA Balloon (NSE Alpha)', 'interventionNames': ['Device: Scoring PTCA Balloon (NSE Alpha)']}], 'interventions': [{'name': 'Super High-Pressure NC PTCA Balloon (OPN NC)', 'type': 'DEVICE', 'description': 'Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.', 'armGroupLabels': ['OPN NC']}, {'name': 'Scoring PTCA Balloon (NSE Alpha)', 'type': 'DEVICE', 'description': 'Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.', 'armGroupLabels': ['NSE Alpha']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Segeberger Kliniken GmbH', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Muenchen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Robert A Byrne, MD BCh PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}, {'name': 'Salvatore Cassese, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'collaborators': [{'name': 'SIS Medical AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}