Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT02946320
Status:
UNKNOWN
Last Update Posted:
2016-10-27
First Post:
2016-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Predilatation Technique for BVS Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal lumen area (MLA) in the BVS (mm2)', 'timeFrame': 'Immediately after BVS implantation', 'description': 'After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area.'}], 'secondaryOutcomes': [{'measure': 'Clinically - driven target vessel revascularization', 'timeFrame': '12 months after the procedure', 'description': 'Patient is followed after BVS implantation in 1,6 and 12 months in the outpatient department.'}, {'measure': 'Eccentricity index', 'timeFrame': 'Immediately after BVS implantation', 'description': 'After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Eccentricity index is calculated as minimal luminal diameter divided by maximal luminal diameter in the MLA segment.'}, {'measure': 'Expansion index', 'timeFrame': 'Immediately after BVS implantation', 'description': 'After BVS implantation, optical coherence tomography is used to measure MLA in the scaffold area. Expansion index is calculated as minimal luminal diameter divided by maximal expected diameter of the non-compliant balloon used for high pressure postdilatation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PCI, bioabsorbable scaffold'], 'conditions': ['Coronary Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal way of predilatation for BVS implantation.', 'detailedDescription': 'Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing percutaneous coronary intervention (PCI)\n* lesion no more than 25 mm in length with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment\n\nExclusion Criteria:\n\n* patients with acurate myocardial infarction (STEMI)\n* patients with specific complex lesion features (left main, aorto ostial, bifurcation with side branch ≥ 2 mm in diameter, extreme angulation proximal or within the target lesion, moderate or heavy calcification proximal or within the target lesion, chronic total occlusion)'}, 'identificationModule': {'nctId': 'NCT02946320', 'acronym': 'OPTI-BVS', 'briefTitle': 'Optimal Predilatation Technique for BVS Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Cardiology Center Agel'}, 'officialTitle': 'Optimal Predilatation Technique for BVS Implantation', 'orgStudyIdInfo': {'id': 'RG4201601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-compliant balloon', 'description': '15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon', 'interventionNames': ['Device: Predilatation with non-compliant balloon']}, {'type': 'EXPERIMENTAL', 'label': 'Scoring balloon', 'description': '15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon', 'interventionNames': ['Device: Predilatation with scoring balloon (Scoroflex)']}, {'type': 'EXPERIMENTAL', 'label': 'Cutting balloon', 'description': '15 patients, before BVS implantation is coronary artery stenosis dilated with this type of balloon', 'interventionNames': ['Device: Predilatation with cutting balloon (Flextome)']}], 'interventions': [{'name': 'Predilatation with non-compliant balloon', 'type': 'DEVICE', 'description': 'Coronary artery stenosis is dilated before BVS implantation with the use of non-compliant balloon (standard procedure). Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)', 'armGroupLabels': ['Non-compliant balloon']}, {'name': 'Predilatation with scoring balloon (Scoroflex)', 'type': 'DEVICE', 'description': 'Coronary artery stenosis is dilated before BVS implantation with the use of scoring balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)', 'armGroupLabels': ['Scoring balloon']}, {'name': 'Predilatation with cutting balloon (Flextome)', 'type': 'DEVICE', 'description': 'Coronary artery stenosis is dilated before BVS implantation with the use of cutting balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)', 'armGroupLabels': ['Cutting balloon']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Petra Jiroušková, Mgr', 'role': 'CONTACT', 'email': 'petra.jirouskova@kca.agel.cz', 'phone': '+420466014182'}], 'overallOfficials': [{'name': 'Ivo Varvařovský, MUDr, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Center AGEL a.s.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiology Center Agel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiology Center Agel', 'investigatorFullName': 'MUDr. Ivo Varvařovský, Ph.D', 'investigatorAffiliation': 'Cardiology Center Agel'}}}}