Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT02853994
Status:
UNKNOWN
Last Update Posted:
2016-08-03
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Major Adverse Cardiac Events (MACE)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Rate of Target Lesion Revascularization (TLR)', 'timeFrame': '12 months'}, {'measure': 'Rate of Target Vessel Failure (TVF)', 'timeFrame': '12 months'}, {'measure': 'Rate of Target Vessel Revascularization (TVR)', 'timeFrame': '12 months'}, {'measure': 'Angiographic success', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DCB', 'DEB', 'Sirolimus', 'PCI', 'ISR', 'SVD', 'Restenosis', 'Bifurcation', 'CAD', 'Coronary artery'], 'conditions': ['CAD']}, 'descriptionModule': {'briefSummary': 'The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications:\n\n* In-stent restenosis lesions: either bare metal or drug eluting stent restenosis\n* Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries\n* Small vessels: treatment of lesions ≤2.75 mm\n* BMS implantation followed by DCB inflation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery diseases (in-stent restenosis, small vessel diseases, bifurcation lesions, de novo lesions)', 'healthyVolunteers': False, 'eligibilityCriteria': "Patient's inclusion and exclusion criteria are per device instructions for use's indications and contraindications.\n\nInclusion criteria:\n\n1. Patient is at least 18 years old\n2. Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.\n\nExclusion criteria:\n\n1. Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds.\n2. Patients with a known hypersensitivity to excipients with phospholipid or related origins.\n3. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.\n4. Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator)\n5. Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter\n6. Patients who cannot receive recommended antiplatelet or anticoagulation therapy."}, 'identificationModule': {'nctId': 'NCT02853994', 'briefTitle': 'Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'MINVASYS'}, 'officialTitle': 'Assessment of Safety and Efficacy of the DEVOIR Sirolimus-Coated Balloon for the Treatment of Native Coronary Artery Lesions in the Real-world Clinical Practice', 'orgStudyIdInfo': {'id': 'P1601'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MINVASYS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}