NCT05586503

EASYII - E-tegra Stent Graft System - Imaging Cohort

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: JOTEC GmbH · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Vascular Aneurysm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ECG-gated CTAs	ECG-gated CTAs will be performed instead of static CTAs comparing to standard of care

Timeline

• Start date: 2022-12-16
• Primary completion: 2029-09-30
• Completion: 2029-12-01
• First posted: 2022-10-19
• Last updated: 2025-04-30

Locations

4 sites across 1 country: Netherlands