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Completed

NCT Number: NCT04058691

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

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).

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Key information

Conditions

Vascular Diseases Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes Pontchaillou University Medical Centre, Rennes, Cedex 9, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

None

Exclusion criteria

None

Treatment and study plan

Surgical Repair

Device

Open surgery

Other names: Frozen Elephant Trunk Technique

Primary outcomes

  1. Primary endpoint

    Time frame: 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 outcomes

  1. Mortality

    Time frame: 1 year

    Mortality rate

  2. Mortality

    Time frame: 3 year

    Mortality rate

  3. Morbidity

    Time frame: 1 year

    Morbidity rate

  4. Morbidity

    Time frame: 3 year

    Morbidity rate

  5. Endoleak type Ib

    Time frame: 1 year

    Rate of endoleak type Ib

  6. Endoleak type Ib

    Time frame: 3 year

    Rate of endoleak type Ib

  7. Endoleak type II

    Time frame: 1 year

    Rate of endoleak type II

  8. Endoleak type II

    Time frame: 3 year

    Rate of endoleak type II

  9. Endoleak type III

    Time frame: 1 year

    Rate of endoleak type III

  10. Endoleak type III

    Time frame: 3 year

    Rate of endoleak type III

  11. Endoleak type IV

    Time frame: 1 year

    Rate of endoleak type IV

  12. Endoleak type IV

    Time frame: 3 year

    Rate of endoleak type IV

  13. Adverse Events

    Time frame: 1 year

    Rate of adverse events

  14. Adverse Events

    Time frame: 3 year

    Rate of adverse events

  15. Reinterventions

    Time frame: 1 year

    Rate of reinterventions

  16. Reinterventions

    Time frame: 3 year

    Rate of reinterventions

  17. Secondary interventions

    Time frame: 1 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)).

  18. Secondary interventions

    Time frame: 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)).

  19. Fully thrombosed false lumen (dissections)

    Time frame: 1 year

    Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft)

  20. Fully thrombosed false lumen (dissections)

    Time frame: 3 year

    Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft)

  21. Partially thrombosed false lumen (dissections)

    Time frame: 1 year

    Rate of patients with partially thrombosed false lumen in the stented area

  22. Partially thrombosed false lumen (dissections)

    Time frame: 3 year

    Rate of patients with partially thrombosed false lumen in the stented area

  23. Patent false lumen (dissections)

    Time frame: 1 year

    Rate of patients with patent false lumen in the stented area

  24. Patent false lumen (dissections)

    Time frame: 3 year

    Rate of patients with patent false lumen in the stented area

Sponsors and collaborators

Lead sponsor

JOTEC GmbH

Industry

Registry information

Official study title

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

Acronym: FEOR

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Aug 15, 2019
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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