Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-11 @ 2:10 AM
Study NCT ID:
NCT02209194
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2014-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017543', 'term': 'Iliac Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2014-07-30', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency', 'timeFrame': 'within 30 days', 'description': 'Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side'}, {'measure': 'Primary Patency', 'timeFrame': '12 months'}, {'measure': 'Primary patency', 'timeFrame': '36 months'}, {'measure': 'Endoleak Type I or III', 'timeFrame': 'within 30 days'}, {'measure': 'Endoleak Type I or III', 'timeFrame': '12 months'}, {'measure': 'Endoleak Type I or III', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Change in aneurysm size', 'timeFrame': 'within 30 days (baseline) and 36 months'}, {'measure': 'Stent graft migration', 'timeFrame': 'within 30 days (baseline) and 36 months'}, {'measure': 'Stent graft dislodgement', 'timeFrame': '36 months'}, {'measure': 'Stent graft kinking', 'timeFrame': '36 months'}, {'measure': 'Distal embolization', 'timeFrame': '36 months'}, {'measure': 'Rate of death', 'timeFrame': '36 months'}, {'measure': 'Rate of complications', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aneurysms', 'vascular disease', 'E-liac Stent Graft', 'E-liac Stent Graft System', 'iliac aneurysm', 'branched stent graft', 'self expanding stent graft'], 'conditions': ['Iliac Aneurysm']}, 'referencesModule': {'references': [{'pmid': '31615695', 'type': 'BACKGROUND', 'citation': 'Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Calavia AR, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results. Eur J Vasc Endovasc Surg. 2019 Dec;58(6):831-838. doi: 10.1016/j.ejvs.2019.06.020. Epub 2019 Oct 12.'}, {'pmid': '30037302', 'type': 'BACKGROUND', 'citation': 'Brunkwall J, Vaquero Puerta C, Heckenkamp J, Egana Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rumenapf G, Buz S, Assadian A, Majd P, Mylonas S, Revilla Calavia A, Theis T, de Blas Bravo M, Pleban E, Schupp J, Esche M, Kocaer C, Hirsch K, Oberhuber A, Schafer JP. Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results. Vascular. 2018 Dec;26(6):647-656. doi: 10.1177/1708538118789510. Epub 2018 Jul 23.'}, {'pmid': '29299625', 'type': 'BACKGROUND', 'citation': 'Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(R) Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm. Cardiovasc Intervent Radiol. 2018 May;41(5):683-691. doi: 10.1007/s00270-017-1868-x. Epub 2018 Jan 3.'}, {'pmid': '27492764', 'type': 'BACKGROUND', 'citation': 'Mylonas SN, Rumenapf G, Schelzig H, Heckenkamp J, Youssef M, Schafer JP, Ahmad W, Brunkwall JS; E-liac Collaborative Group. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg. 2016 Dec;64(6):1652-1659.e1. doi: 10.1016/j.jvs.2016.04.065. Epub 2016 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac implantation side.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with uni- or bilateral aortoiliac or common iliac aneurysm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must comply with the indications for use\n* Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm\n* Unsuitable distal sealing site within the common iliac artery for traditional EVAR\n\nExclusion Criteria:\n\n* Patients with a stenotic internal iliac ostium of \\< 4mm in diameter\n* Patients with severe internal iliac atherosclerosis\n* Patients that do not have a suitable landing area in the main stem of the IIA\n* Patients with pseudoaneurysms\n* Patients with symptomatic and ruptured iliac aneurysms\n* Patients with one of the contraindications as indicated in the instructions for use\n* Patients pretreated with a bifurcated vascular graft\n* Patient with thrombocytopenia\n* Patient with creatinine \\>2.4 mg/dl immediately before the intervention\n* Patient with malignancy needing chemotherapy or radiation\n* Patients who are enrolled in another clinical study\n* Patients with life expectancy of less than 36 months'}, 'identificationModule': {'nctId': 'NCT02209194', 'briefTitle': 'Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System', 'organization': {'class': 'INDUSTRY', 'fullName': 'JOTEC GmbH'}, 'officialTitle': 'PLIANT - A Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With a New Generation of Low Profile E-liac Stent Graft System', 'orgStudyIdInfo': {'id': 'PLIANT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortoiliac Aneurysms Iliac Aneurysms', 'description': 'Endovascular repair of aortoiliac or iliac aneurysms', 'interventionNames': ['Device: E-liac Stent Graft System']}], 'interventions': [{'name': 'E-liac Stent Graft System', 'type': 'DEVICE', 'description': 'Implantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft', 'armGroupLabels': ['Aortoiliac Aneurysms Iliac Aneurysms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Herzzentrum Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Wilhelminenspital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '09113', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Klinikum Chemnitz', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Cologne University Hospital', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Uniklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'UKSH Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '71229', 'city': 'Leonberg', 'country': 'Germany', 'facility': 'Krankenhaus Leonberg', 'geoPoint': {'lat': 48.8, 'lon': 9.01667}}, {'zip': '49074', 'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Marienhospital', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '02-776', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Hematologii i Transfuzjologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '20080', 'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': 'Hospital Universitario Donostia', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Jan Brunkwall, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cologne University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JOTEC GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}