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

Vascular Diseases Clinical Trial

— FEOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058691
• Other study ID #: FEOR
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: JOTEC GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

None

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• Surgical repair
Open surgery

Locations

Country	Name	City	State
France	Clinique de l'Infirmerie Protestante à Lyon	Caluire et Cuire
France	Rennes Pontchaillou University Medical Centre	Rennes	Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Mortality rate	1 year
Secondary	Mortality	Mortality rate	3 year
Secondary	Morbidity	Morbidity rate	1 year
Secondary	Morbidity	Morbidity rate	3 year
Secondary	Endoleak type Ib	Rate of endoleak type Ib	1 year
Secondary	Endoleak type Ib	Rate of endoleak type Ib	3 year
Secondary	Endoleak type II	Rate of endoleak type II	1 year
Secondary	Endoleak type II	Rate of endoleak type II	3 year
Secondary	Endoleak type III	Rate of endoleak type III	1 year
Secondary	Endoleak type III	Rate of endoleak type III	3 year
Secondary	Endoleak type IV	Rate of endoleak type IV	1 year
Secondary	Endoleak type IV	Rate of endoleak type IV	3 year
Secondary	Adverse Events	Rate of adverse events	1 year
Secondary	Adverse Events	Rate of adverse events	3 year
Secondary	Reinterventions	Rate of reinterventions	1 year
Secondary	Reinterventions	Rate of reinterventions	3 year
Secondary	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	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
Secondary	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
Secondary	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
Secondary	Partially thrombosed false lumen (dissections)	Rate of patients with partially thrombosed false lumen in the stented area	1 year
Secondary	Partially thrombosed false lumen (dissections)	Rate of patients with partially thrombosed false lumen in the stented area	3 year
Secondary	Patent false lumen (dissections)	Rate of patients with patent false lumen in the stented area	1 year
Secondary	Patent false lumen (dissections)	Rate of patients with patent false lumen in the stented area	3 year