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Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France

2019-08-21 20:05:48 | BioPortfolio

Summary

The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France. This registry is a requirement of the Haute Autorité de Santé (HAS).

Description

In this registry data will be collected on patients who have been implanted with an E-vita OPEN PLUS Stent Graft System from 15th of July 2014 until May 31st 2019. The E-vita OPEN PLUS Stent Graft System will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-vita OPEN PLUS Stent Graft System. As this registry is a requirement of the Haute Autorité de Santé (HAS), written Informed consent of the patients is not required, however all patients will be provided with a non-objection letter and given the opportunity to refuse to participate.

The period of data collection will be three years starting from the intervention of each patient. Data verification will be performed.

Study Design

Conditions

Vascular Diseases

Intervention

Surgical repair

Status

Not yet recruiting

Source

JOTEC GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-21T20:05:48-0400

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