Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System

Iliac Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209194
• Other study ID #: PLIANT
• Status: Completed
• Start date: June 2014
• Est. completion date: September 2019

Study information

• Verified date: April 2020
• Source: JOTEC GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Iliac Aneurysm

Intervention

Device:
• 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

Locations

Country	Name	City	State
Austria	Herzzentrum Hietzing	Wien
Austria	Wilhelminenspital	Wien
Germany	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
Poland	Instytut Hematologii i Transfuzjologii	Warszawa
Spain	Hospital Universitario Donostia	San Sebastian
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Poland,  Spain, 

References & Publications (4)

Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(®) 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. — View Citation

Brunkwall J, Vaquero Puerta C, Heckenkamp J, Egaña Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rümenapf 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, Schäfer 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. — View Citation

Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, Egaña Barrenechea JM, Szopinski P, Mertikian G, Seifert S, Rümenapf 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, Schäfer 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. — View Citation

Mylonas SN, Rümenapf G, Schelzig H, Heckenkamp J, Youssef M, Schäfer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side	within 30 days
Primary	Primary Patency		12 months
Primary	Primary patency		36 months
Primary	Endoleak Type I or III		within 30 days
Primary	Endoleak Type I or III		12 months
Primary	Endoleak Type I or III		36 months
Secondary	Change in aneurysm size		within 30 days (baseline) and 36 months
Secondary	Stent graft migration		within 30 days (baseline) and 36 months
Secondary	Stent graft dislodgement		36 months
Secondary	Stent graft kinking		36 months
Secondary	Distal embolization		36 months
Secondary	Rate of death		36 months
Secondary	Rate of complications		36 months