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
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Meander Medisch Centrum
Amersfoort
Rijnstate Hospital
Arnhem
Medisch Spectrum Twente
Enschede
Zuyderland Hospital
Heerlen
Time Frame
Start Date: 2022-12-16
Completion Date: 2029-12
Participants
Target number of participants: 25
Treatments
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.
Sponsors
Leads: JOTEC GmbH

This content was sourced from clinicaltrials.gov