EASYII - E-tegra Stent Graft System - Imaging Cohort (EASYII)
Primary Purpose
Vascular Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ECG-gated CTAs
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Aneurysm focused on measuring Abdominal, Aorta, Aneurysm, Endovascular, Repair
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
Sites / Locations
- Meander Medisch Centrum
- Rijnstate HospitalRecruiting
- Medisch Spectrum Twente
- Elisabeth Tweesteden Ziekenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ECG-gated CTA
Arm Description
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.
Outcomes
Primary Outcome Measures
Primary Safety Endpoint:
Rate of 30-day mortality
Primary Imaging Endpoint:
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
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
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
Rate of all-cause mortality
Aneurysm-related mortality
Rate of aneurysm-related mortality
Aneurysm rupture-related mortality
Rate of aneurysm rupture-related mortality
Technical success
Rate of patients with device technical success
Clinical success
Rate of patients with clinical success
Reintervention
Rate of patients with any reintervention
Reintervention-free survival
Rate of patients with reintervention-free survival
Primary limb patency
Rate of patients with primary E-tegra Stent Graft limb patency
Secondary limb patency
Rate of patients with secondary E-tegra Stent Graft limb patency
Stable aneurysm size
Rate of patients with stable aneurysm size
Decreasing aneurysm size
Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter)
Increasing aneurysm size
Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter)
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)
Endoleak Type Ia
Rate of patients with Type Ia endoleak
Endoleak Type Ib
Rate of patients with Type Ib endoleak
Endoleak Type II
Rate of patients with Type II endoleak
Endoleak Type III
Rate of patients with Type III endoleak
Endoleak Type IV
Rate of patients with Type IV endoleak
Endoleak of unknown origin
Rate of patients with endoleak of unknown origin
Stent graft migration
Rate of patients with stent graft migration > 10 mm
Dislodgement
Rate of patients with stent graft dislodgement (full component separation)
Stent fracture
Rate of patients with stent fracture
Stent graft infection
Rate of patients with stent graft infection
Health status
Rate of patients with the same level of health status as prior to surgery
QoL
Rate of patients with the same level of QoL as prior to surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05586503
Brief Title
EASYII - E-tegra Stent Graft System - Imaging Cohort
Acronym
EASYII
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
October 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JOTEC GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Aneurysm
Keywords
Abdominal, Aorta, Aneurysm, Endovascular, Repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ECG-gated CTA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ECG-gated CTAs
Intervention Description
ECG-gated CTAs will be performed instead of static CTAs comparing to standard of care
Primary Outcome Measure Information:
Title
Primary Safety Endpoint:
Description
Rate of 30-day mortality
Time Frame
30 day
Title
Primary Imaging Endpoint:
Description
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
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans
Description
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
Time Frame
prior to discharge, 6, 12, and optionally at 24 months follow-up
Title
Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans
Description
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
Time Frame
prior to discharge, 6, 12, and optionally at 24 months follow-up
Title
Mortality
Description
Rate of all-cause mortality
Time Frame
24 hours, 12, 24, 36, 60 months
Title
Aneurysm-related mortality
Description
Rate of aneurysm-related mortality
Time Frame
30-day, 12, 24, 36, 60 months
Title
Aneurysm rupture-related mortality
Description
Rate of aneurysm rupture-related mortality
Time Frame
30-day, 12, 24, 36, 60 months
Title
Technical success
Description
Rate of patients with device technical success
Time Frame
24 hours
Title
Clinical success
Description
Rate of patients with clinical success
Time Frame
12 months
Title
Reintervention
Description
Rate of patients with any reintervention
Time Frame
30-day, 12, 24, 36, 60 months
Title
Reintervention-free survival
Description
Rate of patients with reintervention-free survival
Time Frame
12 months
Title
Primary limb patency
Description
Rate of patients with primary E-tegra Stent Graft limb patency
Time Frame
30-day, 12, 24, 36, 60 months
Title
Secondary limb patency
Description
Rate of patients with secondary E-tegra Stent Graft limb patency
Time Frame
30-day, 12, 24, 36, 60 months
Title
Stable aneurysm size
Description
Rate of patients with stable aneurysm size
Time Frame
12, 60 months
Title
Decreasing aneurysm size
Description
Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter)
Time Frame
12, 60 months
Title
Increasing aneurysm size
Description
Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter)
Time Frame
12, 60 months
Title
Major adverse events
Description
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)
Time Frame
30-day, 12, 24, 36, 60 months
Title
Endoleak Type Ia
Description
Rate of patients with Type Ia endoleak
Time Frame
12, 60 months
Title
Endoleak Type Ib
Description
Rate of patients with Type Ib endoleak
Time Frame
12, 60 months
Title
Endoleak Type II
Description
Rate of patients with Type II endoleak
Time Frame
12, 60 months
Title
Endoleak Type III
Description
Rate of patients with Type III endoleak
Time Frame
12, 60 months
Title
Endoleak Type IV
Description
Rate of patients with Type IV endoleak
Time Frame
12, 60 months
Title
Endoleak of unknown origin
Description
Rate of patients with endoleak of unknown origin
Time Frame
12, 60 months
Title
Stent graft migration
Description
Rate of patients with stent graft migration > 10 mm
Time Frame
12, 60 months
Title
Dislodgement
Description
Rate of patients with stent graft dislodgement (full component separation)
Time Frame
30-day, 12, 24, 36, 60 months
Title
Stent fracture
Description
Rate of patients with stent fracture
Time Frame
12, 60 months
Title
Stent graft infection
Description
Rate of patients with stent graft infection
Time Frame
30-day, 12, 24, 36, 60 months
Title
Health status
Description
Rate of patients with the same level of health status as prior to surgery
Time Frame
6, 12, 48 to 60 months
Title
QoL
Description
Rate of patients with the same level of QoL as prior to surgery
Time Frame
6, 12, 48 to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Shipp, Dr.
Phone
+49 1757 101 223
Email
christopher.shipp@artivion.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Merz
Phone
+49 1511 539 7681
Email
Juergen.Merz@artivion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Geelkerken, Prof.
Organizational Affiliation
Medisch Spectrum Twente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent van Weel, Dr.
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Reijnen, Prof.
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert H Geelkerken, Prof.
Facility Name
Elisabeth Tweesteden Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan M.M. Heyligers, Dr.
12. IPD Sharing Statement
Learn more about this trial
EASYII - E-tegra Stent Graft System - Imaging Cohort
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