Registry in Patients With Aorto-iliac or Iliac Aneurysms

Vascular Aneurysm Clinical Trial

— PLIANTII  

Official title:

Prospective Multicenter Registry to Examine the Real-world Performance of the E-liac Stent Graft System for Treatment of Uni- or Bilateral Aorto-iliac or Iliac Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03606083
• Other study ID #: PLIANTII
• Status: Recruiting
• Start date: July 15, 2018
• Est. completion date: October 31, 2029

Study information

• Verified date: May 2022
• Source: JOTEC GmbH
• Contact: Heike Fischer, Dr.
• Phone: +49 151 153 97 110
• Email: fischer.heike[@]cryolife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 31, 2029
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 85 years
• Patient must have an aorto-iliac or iliac aneurysm
• Patient must have a unilateral or bilateral iliac aneurysm
• Patient´s anatomy must be suitable for stent graft placement on preoperative angio CT scan
• Patient must be available for the appropriate follow-up times for the duration of the study
• Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to intervention

Exclusion Criteria:

• Female of child bearing potential
• Patients with ruptured iliac aneurysms
• Patients with juxtarenal, pararenal or suprarenal aneurysms
• Patients pretreated with Nellix (Endologix) or Altura (Lombard Medical)
• Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• Patient with malignancy needing chemotherapy or radiation
• Patients with life expectancy of less than 3 years
• Patient minor or under guardianship

Related Conditions & MeSH terms

• Aneurysm
• Iliac Aneurysm
• Vascular Aneurysm

Intervention

Device:
• Endovascular repair
Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Köln	Köln	NRW

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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

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	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
Secondary	Mortality	Rate of all cause mortality in peri-operative periods	24 hours
Secondary	Survival rate	Rate of survival	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Aneurysm size	Rate of patients with decreasing, stable, increasing aneurysm size	12, 24, 36, 60 months
Secondary	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	Secondary patency of EIA / IIA	Rate of patients with secondary patency of EIA / IIA	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Stent graft dislodgement	Rate of patients with stent graft dislodgement	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Endoleak type I	Rate of patients with infrarenal type Ia endoleak	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Endoleak type II	Rate of patients with endoleak type II	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Endoleak type III	Rate of patients with endoleak type III	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Stent fracture	Rate of patients with stent fracture	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Reintervention	Rate patients with reintervention after E-liac Stent Graft implantation	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Claudication	Rate of patients with increasing, stable, decreasing claudication (walking distance without pain)	prior to discharge / 30 days, 12, 24, 36, 60 months
Secondary	Adverse Events	Rate of patients with adverse events (product-related, procedure-related, aneurysm-related)	prior to discharge / 30 days, 12, 24, 36, 60 months