NCT04058691

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

Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: JOTEC GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed description

Data Collection on patients who have been implanted with an E-vita OPEN PLUS Stent Graft System from 15th July 2014 until 31st May 2019. The E-vita OPEN PLUS Stent Graft System was implanted at the discretion of the treating physician. Participating physicians provided their observations collected during routine care for patients he/she had decided to treat with the E-vita OPEN PLUS Stent Graft System. The period of data collection was three years starting from the intervention of each patient. Data verification was performed.

Conditions

• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	Surgical repair	Open surgery

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-02-20
• Completion: 2022-09-30
• First posted: 2019-08-15
• Last updated: 2023-01-25

Locations

2 sites across 1 country: France