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

JOTEC GmbH1 site in 1 country151 target enrollmentMarch 1, 2021

ConditionsVascular Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vascular Aneurysm
Sponsor: JOTEC GmbH
Enrollment: 151
Locations: 1
Primary Endpoint: Mortality
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The EASY post-market clinical follow-up study is undertaken to demonstrate 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 receive an E-tegra Stent Graft for the treatment of infrarenal aortic aneurysm. The E-tegra Stent Graft will be implanted at the discretion of the treating physician. Participating physicians will provide their observations collected during routine care for patients they have decided to treat with the E-tegra stent graft. Informed consent of the patients to the use of their clinical records for study purposes will be obtained before their data will be collected in the post-market clinical follow-up study. All patients will be asked to complete questionaires focussing on the health status (HS) (SF-12) and Quality of Life (QoL) (WHOQOL-BREF). The period of data collection will be approximately 60 months from the date of intervention for each patient. Source document verification will be performed on 100% of the patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans as well as other imaging files (e.g. CEUS, MRT) will be sent to a CoreLab for independent second evaluation. There is no CoreLab screening before inclusion. All adverse events defined prior to study start, will be adjudicated by the Clinical Evaluation Committee (CEC).

Registry

clinicaltrials.gov

Start Date

March 1, 2021

End Date

October 1, 2029

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

JOTEC GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 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.