Clinical trial NCT04058691: Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France
Official title: Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Keywords: Aortic aneurysms
aortic dissections
thoracic
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients with aortic pathologies who have undergone implantation of the E-vita OPEN PLUS Stent Graft System at their physician's discretion since July 15th, 2014.

Brief 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.

Eligibility criteria: Inclusion Criteria:

None

Exclusion Criteria:

None

Primary outcomes:
measure: Primary endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
measure: Mortality
timeFrame: 3 year
measure: Morbidity
timeFrame: 1 year
measure: Morbidity
timeFrame: 3 year
measure: Endoleak type Ib
timeFrame: 1 year
measure: Endoleak type Ib
timeFrame: 3 year
measure: Endoleak type II
timeFrame: 1 year
measure: Endoleak type II
timeFrame: 3 year
measure: Endoleak type III
timeFrame: 1 year
measure: Endoleak type III
timeFrame: 3 year
measure: Endoleak type IV
timeFrame: 1 year
measure: Endoleak type IV
timeFrame: 3 year
measure: Adverse Events
timeFrame: 1 year
measure: Adverse Events
timeFrame: 3 year
measure: Reinterventions
timeFrame: 1 year
measure: Reinterventions
timeFrame: 3 year
measure: Secondary interventions
timeFrame: 1 year
measure: Secondary interventions
timeFrame: 3 year
measure: Fully thrombosed false lumen (dissections)
timeFrame: 1 year
measure: Fully thrombosed false lumen (dissections)
timeFrame: 3 year
measure: Partially thrombosed false lumen (dissections)
timeFrame: 1 year
measure: Partially thrombosed false lumen (dissections)
timeFrame: 3 year
measure: Patent false lumen (dissections)
timeFrame: 1 year
measure: Patent false lumen (dissections)
timeFrame: 3 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes Pontchaillou University Medical Centre
state: Cedex 9
city: Caluire et Cuire
country: France
facility: Clinique de l'Infirmerie Protestante à Lyon
Study officials:
affiliation: Rennes Pontchaillou University Medical Centre
name: Jean-Philippe Verhoye, Prof.
role: PRINCIPAL_INVESTIGATOR
References: