Clinical trial NCT04765176: A PMCF Study in Patients With Infrarenal Aortic Aneurysm Treated With the E-tegra Stent Graft System
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vascular Aneurysm
Keywords: Abdominal
Aorta
Aneurysm
Endovascular
Repair
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients with asymptomatic infrarenal aortic aneurysm who are eligible for the endovascular treatment with the E-tegra Stent Graft System in accordance to the inclusion and exclusion criteria.

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 30-day
Secondary outcomes:
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: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate
name: Michel MP Reijnen, Prof.
role: PRINCIPAL_INVESTIGATOR
References: