Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-22 @ 1:54 PM
Study NCT ID:
NCT02996318
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2016-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2016-12-09', 'studyFirstSubmitQcDate': '2016-12-14', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late lumen loss', 'timeFrame': '6 months', 'description': 'Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': '24 hours', 'description': '≤ 30% final stenosis, TIMI III flow, no flow-limiting dissection at the conclusion of the procedure, and the absence of in-hospital (24 hour after treatment) MACE'}, {'measure': 'MACE (Major adverse cardiac events)', 'timeFrame': '12 months', 'description': 'MACE will be defined as the occurrence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months and 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['DES In-stent Stenosis']}, 'referencesModule': {'references': [{'pmid': '36126132', 'type': 'DERIVED', 'citation': 'Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, Jeger R, Wohrle J, Ong TK, Liew HB, Gori T, Mahfoud F, Nuruddin AA, Woitek F, Abidin IZ, Schwenke C, Schnorr B, Mohd Ali R. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305. doi: 10.1161/CIRCINTERVENTIONS.122.012305. Epub 2022 Sep 20.'}, {'pmid': '30898253', 'type': 'DERIVED', 'citation': 'Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.', 'detailedDescription': 'The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.\n\nPatient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.\n\nIn Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).\n\nThe study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study\n* Patients with ≤ 2 primary drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm distance to the stent.\n\nExclusion Criteria:\n\n* Chronic renal insufficiency with serum creatinine levels \\> 2.0 mg per deciliter\n* Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication\n* Concomitant medical illness associated with a life-expectancy of less than two year\n* Lesion length (ISR) \\> 35 mm, vessel diameter \\< 2.5 mm'}, 'identificationModule': {'nctId': 'NCT02996318', 'acronym': 'FIMLIMUSDCB', 'briefTitle': 'Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnoRa GmbH'}, 'officialTitle': 'Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon', 'orgStudyIdInfo': {'id': 'SI01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sirolimus coated Balloon', 'description': 'treatment of coronary DES-ISR with a sirolimus coated balloon', 'interventionNames': ['Device: Sirolimus coated balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel coated balloon (SeQuent Please)', 'description': 'treatment of coronary DES-ISR with a paclitaxel coated balloon', 'interventionNames': ['Device: Paclitaxel coated balloon (SeQuent Please)']}], 'interventions': [{'name': 'Paclitaxel coated balloon (SeQuent Please)', 'type': 'DEVICE', 'description': 'Paclitaxel coated balloon (SeQuent Please)', 'armGroupLabels': ['Paclitaxel coated balloon (SeQuent Please)']}, {'name': 'Sirolimus coated balloon', 'type': 'DEVICE', 'description': 'Sirolimus coated balloon', 'armGroupLabels': ['Sirolimus coated Balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88300', 'city': 'Kota Kinabalu', 'country': 'Malaysia', 'facility': 'Queen Elizabeth Hospital II', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}, {'zip': '50400', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'National Heart Institute', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '50603', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '94300', 'city': 'Kuching', 'country': 'Malaysia', 'facility': 'Sarawak Genaral Hospital Heart Centre', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '10990', 'city': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Hospital Pulau Pinang', 'geoPoint': {'lat': 3.55, 'lon': 102.56667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnoRa GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}