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The PLIANT II registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the E-liac Stent Graft System.
In this study, patients will be observed who receive one or two E-liac Stent Graft(s) for aorto-iliac or iliac aneurysms. The E-liac Stent Graft(s) will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-liac Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before intervention and before data are being collected.
The period of data collection will be 60 months starting from the intervention for each patient. 100% verification of patient informed consent and essential study documents will be performed at each study site. 60% of patient´s source documentation will be randomly monitored.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular repair | Device | Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD) |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s) | Rate of patients that reach the primary endpoint | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of all cause mortality in peri-operative periods | 24 hours |
| Survival rate | Rate of survival | prior to discharge / 30 days, 12, 24, 36, 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients with uni- or bilateral aorto-iliac or iliac aneurysm, treated with the E-liac Stent Graft System.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Brunkwall, Prof. | Cologne University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Aneurysm size | Rate of patients with decreasing, stable, increasing aneurysm size | 12, 24, 36, 60 months |
| Primary patency of EIA / IIA | Rate of patients with primary patency of EIA / IIA | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Secondary patency of EIA / IIA | Rate of patients with secondary patency of EIA / IIA | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Stent graft dislodgement | Rate of patients with stent graft dislodgement | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Endoleak type I | Rate of patients with infrarenal type Ia endoleak | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Endoleak type Ia in the CIA (isolated iliac aneurysm treatment) | Rate of patients with infrarenal type Ia endoleak | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Endoleak type Ib in the CIA | Rate of patients with endoleak type Ib in the CIA | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Endoleak type Ib in the EIA | Rate of patients with endoleak type Ib in the EIA | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Endoleak type Ib in the IIA | Rate of patients with endoleak type Ib in the IIA | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Endoleak type II | Rate of patients with endoleak type II | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Endoleak type III | Rate of patients with endoleak type III | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Stent fracture | Rate of patients with stent fracture | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Reintervention | Rate patients with reintervention after E-liac Stent Graft implantation | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Claudication | Rate of patients with increasing, stable, decreasing claudication (walking distance without pain) | prior to discharge / 30 days, 12, 24, 36, 60 months |
| Adverse Events | Rate of patients with adverse events (product-related, procedure-related, aneurysm-related) | prior to discharge / 30 days, 12, 24, 36, 60 months |
| 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. |
| 39986435 | Result | Oberhuber A, Deglise S, Richter O, Makaloski V, Bracale U, Isernia G, Tines R, Cappelli A, Dorweiler B, Brunkwall J; PLIANTII Study Collaboration. A Prospective, Multicentre Registry on Thirty Day and One Year Outcomes of the E-liac Stent Graft System in Patients with Unilateral or Bilateral Aorto-iliac or Iliac Aneurysms: The PLIANTII Study. Eur J Vasc Endovasc Surg. 2025 Jun;69(6):847-854. doi: 10.1016/j.ejvs.2025.02.029. Epub 2025 Feb 20. |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |