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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm AAA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endovascular abdominal repair

Intervention Type DEVICE

Other Intervention Names

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EVAR

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No