A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System (EASY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Aneurysm
• Intervention / Treatment: Device: Endovascular Repair

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).

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Christopher Shipp, Dr.; Phone Number: +49 1757 101 223; Email: christopher.shipp@artivion.com
• Study Contact Backup: Name: Juergen Merz; Phone Number: +4915115397681; Email: Juergen.Merz@artivion.com

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815
    • Recruiting
    • Rijnstate Hospital
    • Contact: Michel Reijnen, Prof.; Phone Number: +31628198576; Email: mreijnen@rijnstate.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with asymptomatic infrarenal aortic aneurysm who are eligible for the endovascular treatment with the E-tegra Stent Graft System in accordance to the inclusion and exclusion criteria.

Description

Inclusion Criteria:

• Age ≥ 18
• 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.
• 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

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Michel MP Reijnen, Prof., Rijnstate

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): October 1, 2029

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

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

Drug and device information, study documents

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