EASYII - E-tegra Stent Graft System - Imaging Cohort
- Conditions
- Vascular Aneurysm
- Interventions
- Diagnostic Test: ECG-gated CTAs
- Registration Number
- NCT05586503
- Lead Sponsor
- JOTEC GmbH
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 25
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ECG-gated CTA ECG-gated CTAs 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Secondary limb patency 30-day, 12, 24, 36, 60 months Rate of patients with secondary E-tegra Stent Graft limb patency
Decreasing aneurysm size 12, 60 months Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter)
Endoleak Type III 12, 60 months Rate of patients with Type III endoleak
Stent graft infection 30-day, 12, 24, 36, 60 months Rate of patients with stent graft infection
Stable aneurysm size 12, 60 months Rate of patients with stable aneurysm size
Reintervention 30-day, 12, 24, 36, 60 months Rate of patients with any reintervention
Mortality 24 hours, 12, 24, 36, 60 months Rate of all-cause mortality
Technical success 24 hours Rate of patients with device technical success
Clinical success 12 months Rate of patients with clinical success
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
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
Dislodgement 30-day, 12, 24, 36, 60 months Rate of patients with stent graft dislodgement (full component separation)
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
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
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
Stent fracture 12, 60 months Rate of patients with stent fracture
QoL 6, 12, 48 to 60 months Rate of patients with the same level of QoL as prior to surgery
Increasing aneurysm size 12, 60 months Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter)
Endoleak Type II 12, 60 months Rate of patients with Type II 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
Health status 6, 12, 48 to 60 months Rate of patients with the same level of health status as prior to surgery
Trial Locations
- Locations (4)
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Zuyderland Hospital
🇳🇱Heerlen, Netherlands