Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-02 @ 8:07 AM
Study NCT ID:
NCT01065532
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent strut coverage and stent strut apposition(assessed with OCT)', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target vessel revascularisation (TVR) at 12 months Device success', 'timeFrame': '9 months, 12 months, yearly until 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Restenosis', 'PCI', 'Drug-eluting stent', 'Drug-eluting balloon', 'Optical Coherence Tomography'], 'conditions': ['Restenosis']}, 'referencesModule': {'references': [{'pmid': '25138182', 'type': 'DERIVED', 'citation': "Adriaenssens T, Dens J, Ughi G, Bennett J, Dubois C, Sinnaeve P, Wiyono S, Coosemans M, Belmans A, D'hooge J, Vrolix M, Desmet W. Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial. EuroIntervention. 2014 Aug;10(4):439-48. doi: 10.4244/EIJV10I4A77."}]}, 'descriptionModule': {'briefSummary': 'Different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting Xience V stent (Abbott Vascular) versus use of a paclitaxel-eluting SeQuent Please balloon (BBraun): an optical coherence tomography study.\n\nA prospective, single-centre, randomized clinical trial with clinical, angiographic and OCT follow-up at 9 months.', 'detailedDescription': "Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.\n\nAim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES.\n\nMethods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient older than 18 years\n2. written informed consent available\n3. patient eligible for percutaneous coronary intervention\n4. patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)\n5. Target reference vessel diameter measured by QCA: 2-4 mm\n6. Target lesion length measured by QCA \\< 24 mm\n7. Target lesion stenosis measured by QCA: \\> 70%- \\< 100%\n8. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.\n\nExclusion Criteria:\n\n1. Left ventricular ejection fraction of \\< 30%\n2. Impaired renal function (serum creatinine \\> 2.0 mg/dl)\n3. Target lesion located in bifurcation\n4. Previous and/or planned brachytherapy of target vessel\n5. Lesion of the left main trunk \\> 50%, unprotected\n6. Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus\n7. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)\n8. Patients with a life expectancy of less than one year\n9. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.\n10. Patient currently enrolled in other investigational device or drug trial\n11. Patient not able or willing to adhere to follow-up visits\n12. Patients who previously participated in this study. -'}, 'identificationModule': {'nctId': 'NCT01065532', 'acronym': 'SEDUCE', 'briefTitle': 'SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-eluting Xience V Stent Versus Use of a Paclitaxel-eluting Balloon: Optical Coherence Tomography Study', 'orgStudyIdInfo': {'id': 'EudraCT 2009-011440-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'SeQuent Please Drug-eluting balloon', 'interventionNames': ['Device: Sequent Please Paclitaxel eluting balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Xience V Drug-eluting stent', 'interventionNames': ['Device: Xience V everolimus eluting stent']}], 'interventions': [{'name': 'Sequent Please Paclitaxel eluting balloon', 'type': 'DEVICE', 'description': 'Sequent Please Paclitaxel eluting balloon', 'armGroupLabels': ['1']}, {'name': 'Xience V everolimus eluting stent', 'type': 'DEVICE', 'description': 'Xience V everolimus eluting stent', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Tom Adriaenssens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}, {'name': 'Walter Desmet, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UZ Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}