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

July 24, 2024 updated by: JOTEC GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Arnhem, Netherlands, 6815
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30-day
Rate of all-cause mortality
30-day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 24 hours, 12, 24, 36, 60 months
Rate of all-cause mortality
24 hours, 12, 24, 36, 60 months
Aneurysm-related mortality
Time Frame: 30-day, 12, 24, 36, 60 months
Rate of aneurysm-related mortality
30-day, 12, 24, 36, 60 months
Aneurysm rupture-related mortality
Time Frame: 30-day, 12, 24, 36, 60 months
Rate of aneurysm rupture-related mortality
30-day, 12, 24, 36, 60 months
Technical success
Time Frame: 24 hours
Rate of patients with device technical success
24 hours
Clinical success
Time Frame: 12 months
Rate of patients with clinical success
12 months
Reintervention
Time Frame: 30-day, 12, 24, 36, 60 months
Rate of patients with any reintervention
30-day, 12, 24, 36, 60 months
Reintervention-free survival
Time Frame: 12 months
Rate of patients with reintervention-free survival
12 months
Primary limb patency
Time Frame: 30-day, 12, 24, 36, 60 months
Rate of patients with primary E-tegra Stent Graft limb patency
30-day, 12, 24, 36, 60 months
Secondary limb patency
Time Frame: 30-day, 12, 24, 36, 60 months
Rate of patients with secondary E-tegra Stent Graft limb patency
30-day, 12, 24, 36, 60 months
Stable aneurysm size
Time Frame: 12, 60 months
Rate of patients with stable aneurysm size
12, 60 months
Decreasing aneurysm size
Time Frame: 12, 60 months
Rate of patients with decreasing aneurysm size on CTA scan (≤ 5 mm in maximum diameter)
12, 60 months
Increasing aneurysm size
Time Frame: 12, 60 months
Rate of patients with aneurysm growth on CTA scan (≥ 5 mm in maximum diameter)
12, 60 months
Major adverse events
Time Frame: 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)
30-day, 12, 24, 36, 60 months
Endoleak Type Ia
Time Frame: 12, 60 months
Rate of patients with Type Ia endoleak
12, 60 months
Endoleak Type Ib
Time Frame: 12, 60 months
Rate of patients with Type Ib endoleak
12, 60 months
Endoleak Type II
Time Frame: 12, 60 months
Rate of patients with Type II endoleak
12, 60 months
Endoleak Type III
Time Frame: 12, 60 months
Rate of patients with Type III endoleak
12, 60 months
Endoleak Type IV
Time Frame: 12, 60 months
Rate of patients with Type IV endoleak
12, 60 months
Endoleak of unknown origin
Time Frame: 12, 60 months
Rate of patients with endoleak of unknown origin
12, 60 months
Stent graft migration
Time Frame: 12, 60 months
Rate of patients with stent graft migration > 10 mm
12, 60 months
Dislodgement
Time Frame: 30-day, 12, 24, 36, 60 months
Rate of patients with stent graft dislodgement (full component separation)
30-day, 12, 24, 36, 60 months
Stent fracture
Time Frame: 12, 60 months
Rate of patients with stent fracture
12, 60 months
Stent graft infection
Time Frame: 30-day, 12, 24, 36, 60 months
Rate of patients with stent graft infection
30-day, 12, 24, 36, 60 months
Health status
Time Frame: 6, 12, 48 to 60 months
Rate of patients with the same level of health status as prior to surgery
6, 12, 48 to 60 months
QoL
Time Frame: 6, 12, 48 to 60 months
Rate of patients with the same level of QoL as prior to surgery
6, 12, 48 to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JOTEC GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel MP Reijnen, Prof., Rijnstate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EASY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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