Clinical trial NCT05586503: EASYII - E-tegra Stent Graft System - Imaging Cohort
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vascular Aneurysm
Keywords: Abdominal
Aorta
Aneurysm
Endovascular
Repair
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint:
timeFrame: 30 day
measure: Primary Imaging Endpoint:
timeFrame: 30 day
Secondary outcomes:
measure: Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans
timeFrame: prior to discharge, 6, 12, and optionally at 24 months follow-up
measure: Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans
timeFrame: prior to discharge, 6, 12, and optionally at 24 months follow-up
measure: Mortality
timeFrame: 24 hours, 12, 24, 36, 60 months
measure: Aneurysm-related mortality
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Aneurysm rupture-related mortality
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Technical success
timeFrame: 24 hours
measure: Clinical success
timeFrame: 12 months
measure: Reintervention
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Reintervention-free survival
timeFrame: 12 months
measure: Primary limb patency
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Secondary limb patency
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Stable aneurysm size
timeFrame: 12, 60 months
measure: Decreasing aneurysm size
timeFrame: 12, 60 months
measure: Increasing aneurysm size
timeFrame: 12, 60 months
measure: Major adverse events
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Endoleak Type Ia
timeFrame: 12, 60 months
measure: Endoleak Type Ib
timeFrame: 12, 60 months
measure: Endoleak Type II
timeFrame: 12, 60 months
measure: Endoleak Type III
timeFrame: 12, 60 months
measure: Endoleak Type IV
timeFrame: 12, 60 months
measure: Endoleak of unknown origin
timeFrame: 12, 60 months
measure: Stent graft migration
timeFrame: 12, 60 months
measure: Dislodgement
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Stent fracture
timeFrame: 12, 60 months
measure: Stent graft infection
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Health status
timeFrame: 6, 12, 48 to 60 months
measure: QoL
timeFrame: 6, 12, 48 to 60 months
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Heerlen
country: Netherlands
facility: Zuyderland Hospital
Study officials:
affiliation: Medisch Spectrum Twente
name: Robert H Geelkerken, Prof.
role: PRINCIPAL_INVESTIGATOR
References: