Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System
NCT ID: NCT02209194
Last Updated: 2020-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
47 participants
OBSERVATIONAL
2014-06-30
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aortoiliac Aneurysms Iliac Aneurysms
Endovascular repair of aortoiliac or iliac aneurysms
E-liac Stent Graft System
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
Interventions
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E-liac Stent Graft System
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
Eligibility Criteria
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Inclusion Criteria
* Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm
* Unsuitable distal sealing site within the common iliac artery for traditional EVAR
Exclusion Criteria
* Patients with severe internal iliac atherosclerosis
* Patients that do not have a suitable landing area in the main stem of the IIA
* Patients with pseudoaneurysms
* Patients with symptomatic and ruptured iliac aneurysms
* Patients with one of the contraindications as indicated in the instructions for use
* Patients pretreated with a bifurcated vascular graft
* Patient with thrombocytopenia
* Patient with creatinine \>2.4 mg/dl immediately before the intervention
* Patient with malignancy needing chemotherapy or radiation
* Patients who are enrolled in another clinical study
* Patients with life expectancy of less than 36 months
18 Years
ALL
No
Sponsors
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JOTEC GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Jan Brunkwall, Professor
Role: PRINCIPAL_INVESTIGATOR
Cologne University Hospital
Locations
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Herzzentrum Hietzing
Vienna, , Austria
Wilhelminenspital
Vienna, , Austria
German Heart Center
Berlin, , Germany
Klinikum Chemnitz
Chemnitz, , Germany
Cologne University Hospital
Cologne, , Germany
Uniklinikum Düsseldorf
Düsseldorf, , Germany
UKSH Campus Kiel
Kiel, , Germany
Krankenhaus Leonberg
Leonberg, , Germany
Marienhospital
Osnabrück, , Germany
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Hospital Universitario Donostia
Donostia / San Sebastian, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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PLIANT
Identifier Type: -
Identifier Source: org_study_id
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