EASYII - E-tegra Stent Graft System - Imaging Cohort

NCT05586503 | Active Not Recruiting

• 1 other identifier: EASYII
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Vascular Aneurysm

Keywords

Abdominal; Aorta; Aneurysm; Endovascular; Repair

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (27)

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

  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

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

• Mortality

  24 hours, 12, 24, 36, 60 months

• Aneurysm-related mortality

  30-day, 12, 24, 36, 60 months

• Aneurysm rupture-related mortality

  30-day, 12, 24, 36, 60 months

Study Arms (1)

ECG-gated CTA

EXPERIMENTAL

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

Interventions

ECG-gated CTAs DIAGNOSTIC_TEST

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

ECG-gated CTA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (4)

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

Location

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

Location

Zuyderland Hospital

Heerlen, Netherlands

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert H Geelkerken, Prof.

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: December 16, 2022
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

NL (4)