EASYII - E-tegra Stent Graft System - Imaging Cohort (EASYII)

EASYII - A Post-Market Clinical Follow-up Study (PMCF) in Patients With Infrarenal Aortic Aneurysm Undergoing Endovascular Stenting With the E-tegra Stent Graft System - Imaging Cohort

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vascular Aneurysm
• Intervention / Treatment: Diagnostic test: ECG-gated CTAs

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Meander Medisch Centrum
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Hospital
  • Enschede, Netherlands, 7512 KZ
    • Medisch Spectrum Twente
  • Heerlen, Netherlands
    • Zuyderland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ECG-gated CTA; For study's purposes, patients will undergo ECG-gated CTA scans instead of 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 device fixation and conformability continue up to the 12 months scan.

Diagnostic test: ECG-gated CTAs; ECG-gated CTAs will be performed instead of static CTAs comparing to standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint:	Rate of 30-day mortality	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	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	prior to discharge, 6, 12, and optionally at 24 months follow-up
Mortality	Rate of all-cause mortality	24 hours, 12, 24, 36, 60 months
Aneurysm-related mortality	Rate of aneurysm-related mortality	30-day, 12, 24, 36, 60 months
Aneurysm rupture-related mortality	Rate of aneurysm rupture-related mortality	30-day, 12, 24, 36, 60 months
Technical success	Rate of patients with device technical success	24 hours
Clinical success	Rate of patients with clinical success	12 months
Reintervention	Rate of patients with any reintervention	30-day, 12, 24, 36, 60 months
Reintervention-free survival	Rate of patients with reintervention-free survival	12 months
Primary limb patency	Rate of patients with primary E-tegra Stent Graft limb patency	30-day, 12, 24, 36, 60 months
Secondary limb patency	Rate of patients with secondary E-tegra Stent Graft limb patency	30-day, 12, 24, 36, 60 months
Stable aneurysm size	Rate of patients with stable aneurysm size	12, 60 months
Decreasing aneurysm size	Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter)	12, 60 months
Increasing aneurysm size	Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter)	12, 60 months
Major adverse events	Rate of patients with major adverse events (aneurysm-related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke (mRS ≥ 2), visceral ischemia (bowel ischemia with surgical/endovascular intervention or submission to ICU or bowel necrosis with surgical/endovascular intervention or submission to ICU), new hepatic infarction, new chronic (> 90 days) renal insufficiency/renal failure requiring dialysis, new permanent (> 30 days) paraplegia (modified Tarlov Scale ≤ 2), new permanent (> 30 days) paraparesis (modified Tarlov Scale 3 or 4), lower limb ischemia (increase in Rutherford classification)	30-day, 12, 24, 36, 60 months
Endoleak Type Ia	Rate of patients with Type Ia endoleak	12, 60 months
Endoleak Type Ib	Rate of patients with Type Ib endoleak	12, 60 months
Endoleak Type II	Rate of patients with Type II endoleak	12, 60 months
Endoleak Type III	Rate of patients with Type III endoleak	12, 60 months
Endoleak Type IV	Rate of patients with Type IV endoleak	12, 60 months
Endoleak of unknown origin	Rate of patients with endoleak of unknown origin	12, 60 months
Stent graft migration	Rate of patients with stent graft migration > 10 mm	12, 60 months
Dislodgement	Rate of patients with stent graft dislodgement (full component separation)	30-day, 12, 24, 36, 60 months
Stent fracture	Rate of patients with stent fracture	12, 60 months
Stent graft infection	Rate of patients with stent graft infection	30-day, 12, 24, 36, 60 months
Health status	Rate of patients with the same level of health status as prior to surgery	6, 12, 48 to 60 months
QoL	Rate of patients with the same level of QoL as prior to surgery	6, 12, 48 to 60 months

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Investigators: Principal Investigator: Robert H Geelkerken, Prof., Medisch Spectrum Twente

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Aneurysm; Aorta; Abdominal; Repair; Endovascular
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm
• Other Study ID Numbers: EASYII

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No