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

NCT ID: NCT04058691

Last Updated: 2023-01-25

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-09-30

Brief Summary

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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

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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

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Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Surgical repair

Open surgery

Intervention Type DEVICE

Other Intervention Names

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Frozen Elephant Trunk Technique

Eligibility Criteria

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Inclusion Criteria

None

Exclusion Criteria

None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JOTEC GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe Verhoye, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rennes Pontchaillou University Medical Centre

Locations

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Rennes Pontchaillou University Medical Centre

Rennes, Cedex 9, France

Site Status

Clinique de l'Infirmerie Protestante à Lyon

Caluire-et-Cuire, , France

Site Status

Countries

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France

Other Identifiers

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FEOR

Identifier Type: -

Identifier Source: org_study_id

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