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Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft (TAILOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02692664
Recruitment Status : Active, not recruiting
First Posted : February 26, 2016
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
JOTEC GmbH

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Iliac Aneurysm AAA Device: Endovascular aorto-iliac repair

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
Study Start Date : April 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Groups and Cohorts
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Intervention Details:
  • Device: Endovascular aorto-iliac repair
    Other Name: EVAR

Outcome Measures
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Primary Outcome Measures :
  1. Clinical success [ Time Frame: 30 days follow-up ]

    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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients with unilateral or bilateral common iliac aneurysm, treated with the E-liac Stent Graft System
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692664


Locations
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France
CHU Nantes
Nantes, France
Sponsors and Collaborators
JOTEC GmbH
Investigators
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Principal Investigator: Adrien Kaladji, Dr. CHU Rennes
More Information
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Responsible Party: JOTEC GmbH
ClinicalTrials.gov Identifier: NCT02692664    
Other Study ID Numbers: TAILOR
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by JOTEC GmbH:
iliac side branch
Additional relevant MeSH terms:
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Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases