Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortoiliac Aneurysms Iliac Aneurysms | Endovascular repair of aortoiliac or iliac aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-liac Stent Graft System | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency | Primary patency of the arteria iliaca interna and the arteria iliaca externa on E-liac implantation side | within 30 days |
| Primary Patency | 12 months | |
| Primary patency | 36 months | |
| Endoleak Type I or III | within 30 days | |
| Endoleak Type I or III | 12 months | |
| Endoleak Type I or III | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aneurysm size | within 30 days (baseline) and 36 months | |
| Stent graft migration | within 30 days (baseline) and 36 months | |
| Stent graft dislodgement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with uni- or bilateral aortoiliac or common iliac aneurysm
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan Brunkwall, Professor | Cologne University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Hietzing | Vienna | 1130 | Austria | |||
| Wilhelminenspital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31615695 | Background | 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. | |
| 30037302 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 36 months |
| Stent graft kinking | 36 months |
| Distal embolization | 36 months |
| Rate of death | 36 months |
| Rate of complications | 36 months |
| Vienna |
| 1160 |
| Austria |
| German Heart Center | Berlin | 13353 | Germany |
| Klinikum Chemnitz | Chemnitz | 09113 | Germany |
| Cologne University Hospital | Cologne | 50937 | Germany |
| Uniklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| UKSH Campus Kiel | Kiel | 24105 | Germany |
| Krankenhaus Leonberg | Leonberg | 71229 | Germany |
| Marienhospital | Osnabrück | 49074 | Germany |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-776 | Poland |
| Hospital Universitario Donostia | Donostia / San Sebastian | 20080 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Background |
| 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. |
| 29299625 | Background | 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. |
| 27492764 | Background | 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. |
| ID | Term |
|---|---|
| D017543 | Iliac Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided