Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04011527
Status:
RECRUITING
Last Update Posted:
2022-06-06
First Post:
2019-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2019-06-28', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of in-hospital and long-term cardiovascular adverse events in percent', 'timeFrame': '2 years', 'description': 'Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcified coronary artery lesions'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s', 'detailedDescription': 'A prospective single center registry including all patients treated with Rotational Atherectomy in Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease undergoing a rotational atherectomy in coronary lesion/s', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing a rotational atherectomy of coronary lesion/s\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04011527', 'briefTitle': 'The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s', 'organization': {'class': 'OTHER', 'fullName': 'Segeberger Kliniken GmbH'}, 'officialTitle': 'A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing a Rotational Atherectomy in Coronary Lesion/s', 'orgStudyIdInfo': {'id': 'SK 111 -- 168/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Coronary Artery Disease', 'description': 'Patients with Coronary Artery Disease undergoing a Rotational Atherectomy in Coronary Lesion/s', 'interventionNames': ['Procedure: Rotational Atherectomy in Coronary Lesion/s']}], 'interventions': [{'name': 'Rotational Atherectomy in Coronary Lesion/s', 'type': 'PROCEDURE', 'armGroupLabels': ['Patients with Coronary Artery Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23795', 'city': 'Bad Segeberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gert Richardt, MD', 'role': 'CONTACT', 'email': 'gert.richardt@segebergerkliniken.de', 'phone': '+49 4551 802 4801'}], 'facility': 'Herzzentrum Segeberger Kliniken GmbH', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}], 'centralContacts': [{'name': 'Abdelhakim Allali, MD', 'role': 'CONTACT', 'email': 'allali.abdelhakim@gmail.com', 'phone': '+4945512802', 'phoneExt': '4801'}, {'name': 'Ralph Tölg, P.D., MD', 'role': 'CONTACT', 'email': 'ralph.toelg@segebergerkliniken.de', 'phone': '+4945512802', 'phoneExt': '4801'}], 'overallOfficials': [{'name': 'Gert Richardt, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Herzzentrum Segeberger Kliniken GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Segeberger Kliniken GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}