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

NCT04765176 | Active Not Recruiting

• 1 other identifier: EASY
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Aneurysm

Keywords

Abdominal; Aorta; Aneurysm; Endovascular; Repair

Outcome Measures

Primary Outcomes (1)

• Mortality

  Rate of all-cause mortality

  30-day

Secondary Outcomes (25)

• Mortality

  24 hours, 12, 24, 36, 60 months

• Aneurysm-related mortality

  30-day, 12, 24, 36, 60 months

• Aneurysm rupture-related mortality

  30-day, 12, 24, 36, 60 months

• Technical success

  24 hours

• Clinical success

  12 months

Interventions

Endovascular Repair DEVICE

Endovascular repair of the infrarenal aorta using a AAA stent graft.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, 6815, Netherlands

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Michel MP Reijnen, Prof.

  Rijnstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

NL (1)