NCT02209194 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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.

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

Details for clinical trial NCT02209194

Clinical trial NCT02209194 - References