Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-02-08 @ 5:30 PM
Study NCT ID:
NCT02120859
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2014-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}, {'id': 'D003327', 'term': 'Coronary Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-20', 'studyFirstSubmitDate': '2014-04-19', 'studyFirstSubmitQcDate': '2014-04-20', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiac death or acute myocardial infarction due to target vessel failure', 'timeFrame': '6 month', 'description': 'Cardiac death or acute myocardial infarction occurring in the presence of occlusion or severe flow limitation of the treated vessel'}], 'primaryOutcomes': [{'measure': 'Late lumen loss', 'timeFrame': '6 months', 'description': 'Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 6-month follow-up'}], 'secondaryOutcomes': [{'measure': 'Vessel remodeling assessed by optical coherence tomography', 'timeFrame': '6 months', 'description': 'Lumen and vessel measurements, neointimal proliferation, plaque composition and dissection healing within the treated vessel segment at 6 months assessed by optical coherence tomography (OCT) with 3D-reconstruction'}, {'measure': 'Net lumen gain', 'timeFrame': '6 months', 'description': 'Net lumen gain (NLG, expressed in mm) measured by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter within the treated segment (MLD) at 6-month follow-up and MLD at the lesion site at baseline'}, {'measure': 'Need for revascularization of the treated vessel segment', 'timeFrame': '6 months', 'description': 'Need for revascularization of the treated vessel segment (target lesion revascularization, TLR) driven either clinically or after 6-month angiographic follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PCI', 'Drug-eluting balloon (DEB)', 'Fractional flow reserve (FFR)'], 'conditions': ['Stable Angina', 'Coronary Stenosis']}, 'referencesModule': {'references': [{'pmid': '27379610', 'type': 'DERIVED', 'citation': 'Poerner TC, Duderstadt C, Goebel B, Kretzschmar D, Figulla HR, Otto S. Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography. Clin Res Cardiol. 2017 Jan;106(1):18-27. doi: 10.1007/s00392-016-1019-4. Epub 2016 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.', 'detailedDescription': 'Restenosis rates after plain-old balloon angioplasty (POBA) are with 30-50 % very high. Therefore, this interventional concept is of limited use today. However, dual antiplatelet therapy (DAPT) is not necessary after POBA. Contrary, 3rd generation drug-eluting stents (DES) proved to be very effective showing delayed restenosis only in 5-15%, but require DAPT for at least 6 months. Drug-eluting balloons (DEB) might be a promising trade-off between POBA and DES, since they effectively inhibit neointimal proliferation despite minimal duration of DAPT. However, there is still very limited data on this interventional strategy. Thus, we aimed to investigate feasibility of fractional flow reserve (FFR) - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions, evaluating the 6-month outcomes by angiography and optical coherence tomography (OCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for elective PCI according to the guidelines of European Society of Cardiology, American Heart Association and American College of Cardiology\n* Age \\> 18 years, written consent\n* Native de novo coronary lesion suitable for angioplasty and OCT imaging\n\nExclusion Criteria:\n\n* Pregnancy and breast feeding mother\n* Co-morbidity with an estimated life expectancy of \\< 50 % at 1 year\n* Scheduled major surgery in the next 6 months\n* Not able to give informed written consent or non-compliance\n* Participation in other PCI trial\n* Acute coronary syndromes and cardiogenic shock\n* Known allergy to aspirin, thienopyridines or against taxol derivates\n* Culprit lesion within the proximal 10 mm of the right or left coronary artery\n* Saphenous vein grafts\n* Estimated lesion length \\> 30 mm'}, 'identificationModule': {'nctId': 'NCT02120859', 'acronym': 'OCTOPUS-2', 'briefTitle': 'Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Fractional Flow Reserve - Guided Elective Coronary Angioplasty Using Paclitaxel - Eluting Balloons With Provisional Stent Implantation: A Phase 4 Feasibility Study With 6-Month Follow-up by Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'UKJ-TCP-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FFR - guided DEB angioplasty', 'description': 'DEB-only angioplasty is attempted in all patients. At baseline, quantitative coronary angiography (QCA) and fractional flow reserve (FFR) using an intracoronary standard bolus of adenosine are performed. If FFR at baseline is greater than 0.8, PCI is deferred, otherwise predilation with a non-coated balloon is performed. In case of severe recoil (\\> 50% residual stenosis) or flow-limiting dissection the procedure is deemed not suitable for DEB-only angioplasty and stent implantation is performed at the discretion of the operator. In all other cases, the lesion is treated using a Sequent Please® paclitaxel-eluting balloon (DEB). QCA and FFR measurements are repeated and the result is considered satisfactory if there is no flow-limiting dissection, residual stenosis \\< 40% and FFR \\> 0.8.', 'interventionNames': ['Device: FFR - guided DEB angioplasty']}, {'type': 'OTHER', 'label': 'DEB angioplasty with provisional bare metal stenting', 'description': 'In case of suboptimal results after the FFR-guided DEB angioplasty described above, a bare metal stent is implanted inside the segment previously treated by DEB.', 'interventionNames': ['Device: FFR - guided DEB angioplasty', 'Device: Provisional bare metal stenting']}], 'interventions': [{'name': 'FFR - guided DEB angioplasty', 'type': 'DEVICE', 'otherNames': ['Sequent Please® paclitaxel-eluting balloon (DEB)'], 'description': 'DEB-only angioplasty is attempted in all patients. At baseline, quantitative coronary angiography (QCA) and fractional flow reserve (FFR) using an intracoronary standard bolus of adenosine are performed. If FFR at baseline is greater than 0.8, PCI is deferred, otherwise predilation with a non-coated balloon is performed. In case of severe recoil (\\> 50% residual stenosis) or flow-limiting dissection the procedure is deemed not suitable for DEB-only angioplasty and stent implantation is performed at the discretion of the operator. In all other cases, the lesion is treated using a Sequent Please® paclitaxel-eluting balloon (DEB). QCA and FFR measurements are repeated and the result is considered satisfactory if there is no flow-limiting dissection, residual stenosis \\< 40% and FFR \\> 0.8.', 'armGroupLabels': ['DEB angioplasty with provisional bare metal stenting', 'FFR - guided DEB angioplasty']}, {'name': 'Provisional bare metal stenting', 'type': 'DEVICE', 'otherNames': ['Coroflex Blue® bare metal stent (BMS)'], 'description': 'In case of suboptimal results after the FFR-guided DEB angioplasty described above, a bare metal stent is implanted inside the segment previously treated by DEB.', 'armGroupLabels': ['DEB angioplasty with provisional bare metal stenting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'University Hospital of Jena, Heart Center, Division of Cardiology', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Tudor C Poerner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Jena, Heart Center, Cardiology Division'}, {'name': 'Hans R Figulla, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Jena, Heart Center, Cardiology Divisio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Tudor C. Poerner', 'investigatorFullName': 'Tudor C. Poerner, MD', 'investigatorAffiliation': 'University of Jena'}}}}