Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-30 @ 12:46 AM
Study NCT ID:
NCT04047368
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Coronary Lithoplasty and Rotablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017225', 'term': 'Atherectomy, Coronary'}], 'ancestors': [{'id': 'D017073', 'term': 'Atherectomy'}, {'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal Stent Area (End of the Procedure)', 'timeFrame': '0 days'}], 'secondaryOutcomes': [{'measure': 'Minimal/Mean/Maximal Stent Diameter', 'timeFrame': '0 days'}, {'measure': 'Minimal/Mean/Maximal Lumen area', 'timeFrame': '0 days'}, {'measure': 'Minimal/Mean/Maximal Lumen diameter', 'timeFrame': '0 days'}, {'measure': 'Mean/Maximal Stent area', 'timeFrame': '0 days'}, {'measure': 'Incidence of target lesion failure', 'timeFrame': '0 months; 1 month; 6 months'}, {'measure': 'Incidence of target vessel failure', 'timeFrame': '0 months; 1 month; 6 months'}, {'measure': 'MACE rate', 'timeFrame': '0 months; 1 month; 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'Rotablation', 'Coronary lithoplasty', 'Optical coherence tomography'], 'conditions': ['Coronary Artery Disease', 'Calcified Atheroma']}, 'referencesModule': {'references': [{'pmid': '37012181', 'type': 'DERIVED', 'citation': 'Blachutzik F, Meier S, Weissner M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Elsasser A, Hamm C, Nef H; ROTA.Shock Investigators. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023 Jun 15;197:93-100. doi: 10.1016/j.amjcard.2023.02.028. Epub 2023 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.', 'detailedDescription': 'Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 yrs\n* Stable coronary heart disease or acute coronary syndromes\n* Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.\n* Written informed consent was obtained before the procedure\n* Severely calcified coronary lesion with indication for rotablation\n\nExclusion Criteria:\n\n* Known renal insufficiency (serum creatinine clearance \\<30ml/min/1.73m² or receiving dialysis)\n* Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy\n* Cardiogenic shock\n* Lesion length \\> 32mm\n* Bifurcation lesions requiring 2-Stent-Strategies'}, 'identificationModule': {'nctId': 'NCT04047368', 'briefTitle': 'Comparison of Coronary Lithoplasty and Rotablation', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial', 'orgStudyIdInfo': {'id': 'ROTA.shock'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rotablation', 'interventionNames': ['Procedure: Rotablation']}, {'type': 'EXPERIMENTAL', 'label': 'Coronary Lithoplasty', 'interventionNames': ['Procedure: Coronary Lithoplasty']}], 'interventions': [{'name': 'Rotablation', 'type': 'PROCEDURE', 'description': 'Percutaneous Coronary Intervention using Rotablation', 'armGroupLabels': ['Rotablation']}, {'name': 'Coronary Lithoplasty', 'type': 'PROCEDURE', 'description': 'Percutaneous Coronary Intervention using Lithoplasty', 'armGroupLabels': ['Coronary Lithoplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Florian Blachutzik, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Giessen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Else Kröner-Fresenius Stiftung, Bad Homburg, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}