Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT02468960
Status:
UNKNOWN
Last Update Posted:
2017-10-31
First Post:
2015-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D060050', 'term': 'Angina, Stable'}], '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'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-30', 'studyFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with diagnosis of periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin)', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days.'}, {'measure': 'Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure', 'timeFrame': '12 month folow up'}, {'measure': 'Rate of stent thrombosis according the ARC criteria within 12 months post procedure', 'timeFrame': '12 month follow up'}, {'measure': 'Death or myocardial infarction within 12 months post-procedure', 'timeFrame': '12 month follow up'}], 'primaryOutcomes': [{'measure': 'Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section', 'timeFrame': 'Participants will be followed for the duration of index procedure, an expected average of 1 hour.', 'description': 'Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.'}], 'secondaryOutcomes': [{'measure': 'Procedural success defined as successful delivery of the scaffold', 'timeFrame': 'Participants will be followed for the duration of index procedure, an expected average of 1 hour.'}, {'measure': 'Need for post-dilatation after implantation of the scaffold', 'timeFrame': 'Participants will be followed for the duration of index procedure, an expected average of 1 hour.'}, {'measure': 'Scaffold apposition after post-dilatation', 'timeFrame': 'Participants will be followed for the duration of index procedure, an expected average of 1 hour.', 'description': 'Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.'}, {'measure': 'Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,', 'timeFrame': 'Participants will be followed for the duration of index procedure, an expected average of 1 hour.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'OPN NC', 'Angina', 'Stable', 'Unstable'], 'conditions': ['Coronary Artery Disease', 'Angina', 'Unstable Angina', 'Stable Angina']}, 'descriptionModule': {'briefSummary': 'Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold).\n\nHypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.', 'detailedDescription': 'Study design:\n\nFollowing pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:\n\n* OPN strategy (study group): pre-dilatation with OPN NC ® Super High Pressure PTCA (Percutaneous Transluminal Coronary Angioplasty) balloons\n* standard strategy (control group): pre-dilatation with a standard (compliant) balloon\n\nEnrolment:\n\nRandomization of 50 patients\n\n* 25 in the OPN strategy (study group)\n* 25 in the standard strategy (control group)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years.\n* Able and willing to give informed consent.\n* Willing to comply with specified follow-up evaluations.\n* Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.\n* De novo lesion.\n* Angiographic diameter stenosis \\> 70 % and/or fractional flow reserve \\<0.80.\n* Vessel diameter between 2.5 and 4.0 mm.\n* One- or two vessel disease (defined as diameter stenosis \\> 70 % in vessels with a diameter \\> 2.5 mm).\n* Up to two lesions in one or two vessels can be treated\n\nExclusion Criteria:\n\n* Patient characteristics\n\n * Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.\n * Patient with contraindication for 12 months of dual antiplatelet therapy.\n * ST-elevation myocardial infarction.\n * Any contraindication to the implantation of BVS. Lesion characteristics\n * Visible thrombus in coronary angiography\n * Chronic total occlusion'}, 'identificationModule': {'nctId': 'NCT02468960', 'briefTitle': 'Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'SIS Medical AG'}, 'officialTitle': 'Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study', 'orgStudyIdInfo': {'id': 'OPreNBiS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'OPN strategy (study group)', 'description': 'Interventions planned in this arm are as follows:\n\n* Predilatation with OPN NC balloon catheter.\n* Absorb BVS implantation.\n* Treated segment visualization by OCT.\n* Clinical FU at 12 months.', 'interventionNames': ['Device: Predilatation with OPN NC balloon catheter.', 'Device: Absorb BVS implantation.', 'Procedure: Treated segment visualization by OCT.', 'Other: Clinical FU at 12 months.']}, {'type': 'OTHER', 'label': 'Standard strategy (control group)', 'description': 'Interventions planned in this arm are as follows:\n\n* Predilatation with standard compliant balloon.\n* Absorb BVS implantation.\n* Treated segment visualization by OCT.\n* Clinical FU at 12 months.', 'interventionNames': ['Device: Predilatation with standard compliant balloon.', 'Device: Absorb BVS implantation.', 'Procedure: Treated segment visualization by OCT.', 'Other: Clinical FU at 12 months.']}], 'interventions': [{'name': 'Predilatation with OPN NC balloon catheter.', 'type': 'DEVICE', 'description': 'Target lesion will be prepared by predilatation with OPN NC balloon catheter.', 'armGroupLabels': ['OPN strategy (study group)']}, {'name': 'Predilatation with standard compliant balloon.', 'type': 'DEVICE', 'description': 'Target lesion will be prepared by predilatation with standard balloon catheter (compliant).', 'armGroupLabels': ['Standard strategy (control group)']}, {'name': 'Absorb BVS implantation.', 'type': 'DEVICE', 'description': 'After lesion preparation implantation of BVS Absorb scaffold will be performed.', 'armGroupLabels': ['OPN strategy (study group)', 'Standard strategy (control group)']}, {'name': 'Treated segment visualization by OCT.', 'type': 'PROCEDURE', 'description': 'Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).', 'armGroupLabels': ['OPN strategy (study group)', 'Standard strategy (control group)']}, {'name': 'Clinical FU at 12 months.', 'type': 'OTHER', 'description': 'All patients will be clinically followed for 12 months.', 'armGroupLabels': ['OPN strategy (study group)', 'Standard strategy (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Luzernen Kantonsspital, Spitalstrasse 16', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Florim Cuculi, Prof. dr', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SIS Medical AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}