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

Completed

• Conditions: Vascular Diseases

• Registration Number: NCT04058691
• Lead Sponsor: JOTEC GmbH

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.

Study Timeline

• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Study Start: 2019-11-01
• Primary Completion: 2020-02-20
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

None

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	3 year	Rate of adverse events
Endoleak type IV	3 year	Rate of endoleak type IV
Reinterventions	3 year	Rate of reinterventions
Endoleak type Ib	3 year	Rate of endoleak type Ib
Fully thrombosed false lumen (dissections)	3 year	Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft)
Mortality	3 year	Mortality rate
Morbidity	3 year	Morbidity rate
Secondary interventions	3 year	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)).
Partially thrombosed false lumen (dissections)	3 year	Rate of patients with partially thrombosed false lumen in the stented area
Patent false lumen (dissections)	3 year	Rate of patients with patent false lumen in the stented area
Endoleak type III	3 year	Rate of endoleak type III
Endoleak type II	3 year	Rate of endoleak type II

Trial Locations

Locations (2)

Clinique de l'Infirmerie Protestante à Lyon; 🇫🇷 Caluire et Cuire, France

Rennes Pontchaillou University Medical Centre; 🇫🇷 Rennes, Cedex 9, France