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

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

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).

Study Overview

• Status: Completed
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: Surgical repair

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Caluire et Cuire, France, 69300
    • Clinique de l'Infirmerie Protestante à Lyon
  • Cedex 9
    • Rennes, Cedex 9, France, 35033
      • Rennes Pontchaillou University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

None

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint	The primary endpoint is a composite endpoint of morbi-mortality defined as following: Mortality rate; Morbidity rate including neurological complications, visceral malperfusion, and renal complications. Neurological complications comprise new cerebrovascular accident (CVA)/stroke, spinal cord ischemia, paraparesis, paraplegia as reported in the eCRF. Visceral malperfusion includes new bowel obstruction and visceral ischemia/infarction as reported in the eCRF. Renal complications comprise new renal insufficiency and renal insufficiency requiring dialysis as reported in the eCRF.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate	1 year
Mortality	Mortality rate	3 year
Morbidity	Morbidity rate	1 year
Morbidity	Morbidity rate	3 year
Endoleak type Ib	Rate of endoleak type Ib	1 year
Endoleak type Ib	Rate of endoleak type Ib	3 year
Endoleak type II	Rate of endoleak type II	1 year
Endoleak type II	Rate of endoleak type II	3 year
Endoleak type III	Rate of endoleak type III	1 year
Endoleak type III	Rate of endoleak type III	3 year
Endoleak type IV	Rate of endoleak type IV	1 year
Endoleak type IV	Rate of endoleak type IV	3 year
Adverse Events	Rate of adverse events	1 year
Adverse Events	Rate of adverse events	3 year
Reinterventions	Rate of reinterventions	1 year
Reinterventions	Rate of reinterventions	3 year
Secondary interventions	Rate of secondary interventions: TAA: A planned additional endovascular intervention with a TAA stent graft in the downstream aorta. Treatment of the dissection distally to the targeted pathology that was initially treated using the Evita OPEN PLUS Stent Graft is not a reintervention but an additional intervention (secondary intervention (s)).	1 year
Secondary interventions	Rate of secondary interventions: TAA: A planned additional endovascular intervention with a TAA stent graft in the downstream aorta. Treatment of the dissection distally to the targeted pathology that was initially treated using the Evita OPEN PLUS Stent Graft is not a reintervention but an additional intervention (secondary intervention (s)).	3 year
Fully thrombosed false lumen (dissections)	Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft)	1 year
Fully thrombosed false lumen (dissections)	Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft)	3 year
Partially thrombosed false lumen (dissections)	Rate of patients with partially thrombosed false lumen in the stented area	1 year
Partially thrombosed false lumen (dissections)	Rate of patients with partially thrombosed false lumen in the stented area	3 year
Patent false lumen (dissections)	Rate of patients with patent false lumen in the stented area	1 year
Patent false lumen (dissections)	Rate of patients with patent false lumen in the stented area	3 year

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Investigators: Principal Investigator: Jean-Philippe Verhoye, Prof., Rennes Pontchaillou University Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Aortic aneurysms; aortic dissections; thoracic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: FEOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No