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

Sponsor

JOTEC GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04765176

Collaborator

(none)

250

Enrollment

Location

103

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Aneurysm	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2029

Outcome Measures

Primary Outcome Measures

Mortality [30-day]
Rate of all-cause mortality

Secondary Outcome Measures

Mortality [24 hours, 12, 24, 36, 60 months]
Rate of all-cause mortality
Aneurysm-related mortality [30-day, 12, 24, 36, 60 months]
Rate of aneurysm-related mortality
Aneurysm rupture-related mortality [30-day, 12, 24, 36, 60 months]
Rate of aneurysm rupture-related mortality
Technical success [24 hours]
Rate of patients with device technical success
Clinical success [12 months]
Rate of patients with clinical success
Reintervention [30-day, 12, 24, 36, 60 months]
Rate of patients with any reintervention
Reintervention-free survival [12 months]
Rate of patients with reintervention-free survival
Primary limb patency [30-day, 12, 24, 36, 60 months]
Rate of patients with primary E-tegra Stent Graft limb patency
Secondary limb patency [30-day, 12, 24, 36, 60 months]
Rate of patients with secondary E-tegra Stent Graft limb patency
Stable aneurysm size [12, 60 months]
Rate of patients with stable aneurysm size
Decreasing aneurysm size [12, 60 months]
Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter)
Increasing aneurysm size [12, 60 months]
Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter)
Major adverse events [30-day, 12, 24, 36, 60 months]
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)
Endoleak Type Ia [12, 60 months]
Rate of patients with Type Ia endoleak
Endoleak Type Ib [12, 60 months]
Rate of patients with Type Ib endoleak
Endoleak Type II [12, 60 months]
Rate of patients with Type II endoleak
Endoleak Type III [12, 60 months]
Rate of patients with Type III endoleak
Endoleak Type IV [12, 60 months]
Rate of patients with Type IV endoleak
Endoleak of unknown origin [12, 60 months]
Rate of patients with endoleak of unknown origin
Stent graft migration [12, 60 months]
Rate of patients with stent graft migration > 10 mm
Dislodgement [30-day, 12, 24, 36, 60 months]
Rate of patients with stent graft dislodgement (full component separation)
Stent fracture [12, 60 months]
Rate of patients with stent fracture
Stent graft infection [30-day, 12, 24, 36, 60 months]
Rate of patients with stent graft infection
Health status [6, 12, 48 to 60 months]
Rate of patients with the same level of health status as prior to surgery
QoL [6, 12, 48 to 60 months]
Rate of patients with the same level of QoL as prior to surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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