EASYII - E-tegra Stent Graft System - Imaging Cohort

N/AActive Not RecruitingNCT05586503

JOTEC GmbH25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vascular Aneurysm

Interventions

ECG-gated CTAsDIAGNOSTIC_TEST

ECG-gated CTAs will be performed instead of static CTAs comparing to standard of care

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 65 * Patient must have an * infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm in males, or * infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cm per year * Patient is elegible for treatment inside the instructions for use of the E-tegra Stent Graft System * Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 6 months, 12 months, and annually thereafter 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 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 increase over a 15 mm length * Patient in which the E-tegra Stent Graft System is used in combination with proximal or distal extenders of another company. * Patient who is planned to be treated with an adjunctive aortic bare metal stent or a fenestrated stent graft * Patient who is planned to be treated with a chimney / chimneys in the renal or visceral vessels * Patient who is planned to be treated with an iliac branch device or parallel grafts in the iliac vessels * Patient with genetic connective tissue disease (e.g. Marfan syndrome or Ehlers-Danlos syndrome) * Patient with eGFR \< 45 ml/min/1.73 m2 before the intervention Patient had or planned to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the E-tegra Stent Graft System * Patient with other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with a limited life expectancy 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 allow inclusion in this trial

Locations (4)

Meander Medisch Centrum

Amersfoort, Netherlands

Rijnstate Hospital

Arnhem, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Zuyderland Hospital

Heerlen, Netherlands

Outcomes

Primary Outcomes

Primary Safety Endpoint:

Rate of 30-day mortality

Time frame: 30 day

Primary Imaging Endpoint:

Quantifying stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time at 30 day follow-up

Time frame: 30 day

Secondary Outcomes

Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans

Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans at prior to discharge, 6, 12, and optionally at 24 months follow-up

Time frame: prior to discharge, 6, 12, and optionally at 24 months follow-up

Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans

Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans at prior to discharge, 6, 12, and optionally at 24 months follow-up

Time frame: prior to discharge, 6, 12, and optionally at 24 months follow-up

Mortality

Rate of all-cause mortality

Time frame: 24 hours, 12, 24, 36, 60 months

Aneurysm-related mortality

Rate of aneurysm-related mortality

Time frame: 30-day, 12, 24, 36, 60 months

Aneurysm rupture-related mortality

Rate of aneurysm rupture-related mortality

Time frame: 30-day, 12, 24, 36, 60 months

Data from ClinicalTrials.gov

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