EASYII - E-tegra Stent Graft System - Imaging Cohort

Sponsor

JOTEC GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05586503

Collaborator

(none)

Enrollment

Locations

Arm

81.5

Anticipated Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Aneurysm	Diagnostic Test: ECG-gated CTAs	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 16, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Oct 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: ECG-gated CTAs ECG-gated CTAs will be performed instead of static CTAs comparing to standard of care

Arm

Intervention/Treatment

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.

Diagnostic Test: ECG-gated CTAs

ECG-gated CTAs will be performed instead of static CTAs comparing to standard of care

Outcome Measures

Primary Outcome Measures

Primary Safety Endpoint: [30 day]
Rate of 30-day mortality
Primary Imaging Endpoint: [30 day]
Quantifying stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time at 30 day follow-up

Secondary Outcome Measures

Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans [prior to discharge, 6, 12, and optionally at 24 months follow-up]
Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans at prior to discharge, 6, 12, and optionally at 24 months follow-up
Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans [prior to discharge, 6, 12, and optionally at 24 months follow-up]
Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans at prior to discharge, 6, 12, and optionally at 24 months follow-up
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:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Meander Medisch Centrum	Amersfoort	Netherlands	3813 TZ
2	Rijnstate Hospital	Arnhem	Netherlands	6815 AD
3	Medisch Spectrum Twente	Enschede	Netherlands	7512 KZ
4	Elisabeth Tweesteden Ziekenhuis	Tilburg	Netherlands	5022 GC