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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02692664
Other study ID # TAILOR
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2016
Est. completion date June 2025

Study information

Verified date June 2023
Source JOTEC GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms. Objectives of this post-market registry are: Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date June 2025
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Unilateral or bilateral aorto-iliac or iliac aneurysm - Suitable for endovascular repair - Patient must be compliant with life- long follow-up investigations - >18 years old - lliac/femoral access vessel morphology compatible with the implantation procedure and the 18Fr (6mm OD) delivery system - Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm = 20mm - Diameter of the common iliac artery in the proximal landing area: 12mm to 17mm - Non-aneurysmal external iliac artery segment distal to the aneurysm =15mm - Diameter of the external iliac artery in the distal landing area: 8mm to 13mm - Non-aneurysmal internal iliac artery segment distal to the aneurysm =15mm - Angle between external iliac artery and internal iliac artery =50° - Thrombus free iliac lumen in the area of iliac bifurcation to open hypogastric side branch and to implant covered stent =18mm - Sufficiently open internal iliac arterv ostium - Patients must comply with the instructions for use. - Patients with common iliac aneurysm with a diameter =30mm when isolated or common iliac aneurysm with a diameter >25mm when associated with an abdominal aortic aneurysm - Unilateral or bilateral common iliac aneurysm - Patient's anatomy must be fit for stent graft placement on preoperative angio CT scan. - Patient is affiliated to the social security or equivalent system. - The 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 from. Exclusion Criteria: - Patients who do not meet the instructions for use - Patients with one of the contraindications as indicated in the instructions for use - 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 (maximum diameter in landing area <12mm) - Patients with pseudoaneurysms - Patients with symptomatic and ruptured iliac aneurysms - Patients pretreated with a AAA stent graft or a bifurcated vascular graft - Patient with thrombocytopenia - Patient with an estimated glomerular filtration rate < 30 ml/min/1,73m2 immediately before the Intervention - Female of child bearing potential - In the lnvestigator's opinion patient has (a) eo-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements, or impact the scientific integrity of the study - 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 36 months - Patient minor or under guardianship

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Endovascular aorto-iliac repair


Locations

Country Name City State
France CHU Nantes Nantes
France CHU Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
JOTEC GmbH

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical success Clinical success related to the E-liac Stent Graft combines the following criteria (adapted from Chaikof 2002):
Clinical success should be reported on an intent-to-treat Basis
requires successful deployment of the E-liac Stent Graft at the intended location without
Death as a result of iliac aneurysm-related treatment
Type I or III endoleak
E-liac Stent Graft infection
E-liac Stent Graft thrombosis (including internal iliac artery thrombosis)
Aneurysm growth >3mm in maximum diameter for common iliac aneurysm and >5mm in maximum diameter for aortic aneurysm at 12, 24, and 36 months follow-up
Common iliac aneurysm rupture
Conversion to open repair
Failure of E-liac Stent Graft integrity
30 days follow-up
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Terminated NCT02485496 - E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
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Not yet recruiting NCT05409118 - JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization N/A
Terminated NCT02393716 - Endurant Evo US Clinical Trial N/A