E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

NCT02485496 | Terminated

• 1 other identifier: SECURE
• Study Type: observational
• Target: 38
• Locations: 5 countries
• Sites: 10

Brief Summary

The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.

Conditions

Abdominal Aortic Aneurysm; AAA

Outcome Measures

Primary Outcomes (1)

• Rate of aneurysm rupture and aneurysm related death

  2 years

Interventions

Endovascular abdominal repair DEVICE

Also known as: EVAR

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 infrarenal aortic or aorto-iliac aneurysm who are eligible for treatment with an abdominal stent graft according to the instructions for use for the E-tegra stent graft system, and scheduled for implantation of the E-tegra stent graft system at their physician's discretion in accordance with the inclusion and exclusion criteria.

You may qualify if:

• Patients must comply with the indications for use
• Patient must have an infrarenal aortic aneurysm with diameter \>5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months
• Patient must be available for the appropriate follow-up times for the duration of the study
• Patient has signed the informed consent before intervention

You may not qualify if:

• Patients with one of the contraindications as indicated in the instructions for use
• Patients with infectious aneurysm
• Patients with inflammatory aneurysm
• Patients with pseudoaneurysm
• Patients with ruptured or traumatic aneurysm
• Patients with suprarenal, juxtarenal, or pararenal aneurysm
• Patients with aortic dissection
• Patients with a reversed conical neck that is defined as a \>3mm distal increase over a 15mm length
• Patients who have a congenital degenerative Collagen disease or connective tissue disorder
• Patients with thrombocytopenia
• Patients with creatinine \>2.4 mg/dl immediately before the Intervention
• Patients with hyperthyreosis
• Patients with malignancy needing chemotherapy or Radiation
• Patients who are enrolled in another clinical study
• Patients with life expectancy of less than 24 months

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (10)

CHU Nantes

Nantes, 44093, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Klinikum Chemnitz

Chemnitz, 09116, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Szpital Uniwersytecki im. dr. Antoniego Jurasza

Bydgoszcz, 85-094, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, 20-081, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, 02-097, Poland

Location

Hospital Joan XXIII

Tarragona, Spain

Location

Hospital Clinico Universitario Valladolid

Valladolid, 47005, Spain

Location

Inselspital - Universitätsspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Sven Seifert, Dr.

  Klinikum Chemnitz

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

FR (2); DE (2); PL (3); ES (2); CH (1)