Clinical trial NCT02209194: Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iliac Aneurysm
Keywords: aneurysms
vascular disease
E-liac Stent Graft
E-liac Stent Graft System
iliac aneurysm
branched stent graft
self expanding stent graft
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with uni- or bilateral aortoiliac or common iliac aneurysm

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients must comply with the indications for use
* 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 a stenotic internal iliac ostium of \< 4mm in diameter
* 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

Primary outcomes:
measure: Primary patency
timeFrame: within 30 days
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Herzzentrum Hietzing
city: Wien
country: Austria
facility: Wilhelminenspital
city: Berlin
country: Germany
facility: German Heart Center
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Cologne
country: Germany
facility: Cologne University Hospital
city: Düsseldorf
country: Germany
facility: Uniklinikum Düsseldorf
city: Kiel
country: Germany
facility: UKSH Campus Kiel
city: Leonberg
country: Germany
facility: Krankenhaus Leonberg
city: Osnabrück
country: Germany
facility: Marienhospital
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Cologne University Hospital
name: Jan Brunkwall, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.