Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-28 @ 4:25 PM
Study NCT ID:
NCT04014595
Status:
UNKNOWN
Last Update Posted:
2022-06-08
First Post:
2019-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
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': 100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2019-06-28', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ratio of OCT-measured stent excentricity index', 'timeFrame': 'Intra-procedural', 'description': 'Defined as the ratio of minimal lumen diameter and the maximal lumen diameter per cross section at the end of index procedure'}], 'primaryOutcomes': [{'measure': 'Primary endpoint: Numerical in-stent acute lumen gain in mm', 'timeFrame': 'At the end of the index procedure', 'description': 'The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.'}, {'measure': 'Co-primary OCT endpoint: Ratio of stent expansion index (SEI)', 'timeFrame': 'At the end of the index procedure', 'description': 'The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure'}], 'secondaryOutcomes': [{'measure': 'Numerical in-stent late lumen loss at 9 month follow-up angiography in mm', 'timeFrame': '9 months follow-up', 'description': 'In-stent late lumen loss at 9 month follow-up angiography defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD)and the in-stent MLD at 9-month followup angiography will be adopted as a co-primary endpoint.'}, {'measure': 'Rate of angiographic success in percent', 'timeFrame': 'Peri-procedural', 'description': "'Angiographic Success' defined as successful stent delivery and expansion with attainment of \\< 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow."}, {'measure': 'Rate of strategy success in percent', 'timeFrame': 'Peri-procedural', 'description': "'Strategy Success' defined as successful stent delivery and expansion with attainment of \\< 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow without stent failure."}, {'measure': 'Rate of target vessel failure in percent', 'timeFrame': '9 months, 1 and 2 years follow-up', 'description': 'Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization at 9 months, 1 and 2 years.'}, {'measure': 'Rate of in-segment binary restenosis at 9 months in percent', 'timeFrame': '9 months follow-up', 'description': 'In-segment binary restenosis at 9 months'}, {'measure': 'Rate of stent thrombosis in percent', 'timeFrame': '9 months, 1 and 2 years follow-up and final 5 years follow-up', 'description': 'Stent thrombosis'}, {'measure': 'Rate of peri-procedural myocardial infarction in percent', 'timeFrame': 'Peri-procedural', 'description': 'Peri-procedural myocardial infarction'}, {'measure': 'Rate of vessel perforation in percent', 'timeFrame': 'Peri-procedural', 'description': 'Rate of vessel perforation'}, {'measure': 'Numerical procedural duration in min', 'timeFrame': 'Peri-procedural', 'description': 'Procedural duration'}, {'measure': 'Numerical contrast dye amount in ml', 'timeFrame': 'Peri-procedural', 'description': 'Procedural contrast dye amount'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcified coronary lesions'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.', 'detailedDescription': 'A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease subjected to percutaneous revascularization of the native coronary arteries and fullfilling all of the inclusion criteria and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical inclusion criteria\n\n1. Age above 18 years and consentable\n2. Angiographically proven coronary artery disease\n3. Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve\n4. Written informed consent\n\nAngiographic inclusion criteria\n\n1. De-novo lesion in a native coronary artery\n2. Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation\n3. Luminal diameter reduction of 50-100% by visual estimation\n4. Severe calcification of the target lesion (for definition see appendix)\n\nExclusion Criteria:\n\nClinical exclusion criteria\n\n1. Myocardial infarction (within 1 week)\n2. Decompensated heart failure\n3. Limited long term prognosis due to other conditions\n\nAngiographic exclusion criteria\n\n1. Target lesion is in a coronary artery bypass graft\n2. Target lesion is an in-stent restenosis\n3. Target vessel thrombus'}, 'identificationModule': {'nctId': 'NCT04014595', 'briefTitle': 'PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons', 'organization': {'class': 'OTHER', 'fullName': 'Segeberger Kliniken GmbH'}, 'officialTitle': 'The Evaluation of a Strategy to PREPARE Severely CALCified Coronary Lesions With a Combination Of Rotational Atherectomy and Modified BallOons Trial (PREPARE-CALC- COMBO)', 'orgStudyIdInfo': {'id': 'SK 110 -- 168/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rotational atherectomy + Cutting Balloon', 'description': 'Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions', 'interventionNames': ['Procedure: Rotational atherectomy in combination with cutting balloon']}], 'interventions': [{'name': 'Rotational atherectomy in combination with cutting balloon', 'type': 'PROCEDURE', 'description': 'Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.', 'armGroupLabels': ['Rotational atherectomy + Cutting Balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Herzzentrum Segeberger Kliniken GmbH', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}], 'overallOfficials': [{'name': 'Gert Richardt, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Herzzentrum Segeberger Kliniken GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Segeberger Kliniken GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}