EASYII - E-tegra Stent Graft System - Imaging Cohort

Last updated: April 29, 2025
Sponsor: JOTEC GmbH
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

ECG-gated CTAs

Clinical Study ID

NCT05586503
EASYII
  • Ages > 65
  • All Genders

Study Summary

The objective of the study is to assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time as well as to evaluate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 65

  • Patient must have an

  • infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm inmales, or

  • infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cmper year

  • Patient is elegible for treatment inside the instructions for use of the E-tegraStent Graft System

  • Patient is able and willing to undergo follow-up imaging and examinations prior todischarge from the hospital, at 30 days and 6 months, 12 months, and annuallythereafter until 5 years follow-up

  • Patient understands and has signed the Informed Consent Form prior to intervention

  • Patient has a life expectancy of at least 5 years

Exclusion

Exclusion Criteria:

  • Patient with severe calcification or thrombi in the proximal sealing zone

  • Patient with infectious aneurysm

  • Patient with inflammatory aneurysm

  • Patient with pseudoaneurysm

  • Patient with symptomatic aneurysm

  • Patient with ruptured or traumatic aneurysm

  • Patient with suprarenal, juxtarenal, or pararenal aneurysm

  • Patient with aortic dissection

  • Patient with a reversed conical neck that is defined as a > 3 mm distal increaseover a 15 mm length

  • Patient in which the E-tegra Stent Graft System is used in combination with proximalor distal extenders of another company.

  • Patient who is planned to be treated with an adjunctive aortic bare metal stent or afenestrated stent graft

  • Patient who is planned to be treated with a chimney / chimneys in the renal orvisceral vessels

  • Patient who is planned to be treated with an iliac branch device or parallel graftsin the iliac vessels

  • Patient with genetic connective tissue disease (e.g. Marfan syndrome orEhlers-Danlos syndrome)

  • Patient with eGFR < 45 ml/min/1.73 m2 before the intervention Patient had or plannedto have a major surgical or interventional procedure within 30 days before or 30days after the planned implantation of the E-tegra Stent Graft System

  • Patient with other medical condition that may cause the patient to be non-compliantwith the protocol, confound the results, or is associated with a limited lifeexpectancy of less than five years (i.e. heart failure, active malignancy (progressive, stable or partial remission))

  • Patient who has been enrolled in another active clinical trial that does not allowinclusion in this trial

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: ECG-gated CTAs
Phase:
Study Start date:
December 16, 2022
Estimated Completion Date:
December 31, 2029

Study Description

In this study, patients will be observed who are treated with an aorto-iliac bifurcated or aorto-uni-iliac configuration of the E-tegra Stent Graft System for the treatment of an infrarenal aortic or aorto-iliac aneurysm. The E-tegra Stent Graft components will be implanted at the discretion of the treating physician according to the local protocols.

EASYII is an interventional, non-randomized, post-market, multicentre study. The EASYII study is conducted to further assess, within the scope of the intended purpose, the E-tegra Stent Graft, including the study specific additional exam (visit at 6 months). The patients will undergo ECG-gated CTA scans instead of static CTA scans at pre-operative planning, prior to discharge, 30 days, 6 months, 12 months in order to assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time. An additional ECG-gated CTA scan may optionally be performed at 24 months if the stent fixation (barbs) and stent graft conformability continue up to the 12 months scan.

Connect with a study center

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ
    Netherlands

    Site Not Available

  • Rijnstate Hospital

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, 7512 KZ
    Netherlands

    Site Not Available

  • Zuyderland Hospital

    Heerlen,
    Netherlands

    Site Not Available

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

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