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

Vascular Aneurysm Clinical Trial

— EASY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04765176
• Other study ID #: EASY
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: October 1, 2029

Study information

• Verified date: January 2023
• Source: JOTEC GmbH
• Contact: Christopher Shipp, Dr.
• Phone: +49 1757 101 223
• Email: christopher.shipp[@]artivion.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 1, 2029
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Vascular Aneurysm

Intervention

Device:
• Endovascular Repair
Endovascular repair of the infrarenal aorta using a AAA stent graft.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Country where clinical trial is conducted

Netherlands, 

Outcome

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