PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO

  • STATUS
    Recruiting
  • End date
    Mar 31, 2026
  • participants needed
    100
  • sponsor
    JOTEC GmbH
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Updated on 10 August 2021
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Summary

The NEOS-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending thoracic aorta.

Description

In this study, patients will be observed who receive an E-vita OPEN NEO implant for the treatment of thoracic aneurysm or acute or chronic thoracic dissection. E-vita OPEN NEO will be implanted according to the instructions for use and at the discretion of the treating physician. Participating physicians will provide their observations collected during routine care for patients treated with E-vita OPEN NEO. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection. The period of data collection will be approximately 24 months from the date of intervention for each patient. Source data verification will be performed on 100% of the patients; data from all the visits that was provided in the database will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.

Details
Condition Vascular Aneurysm
Treatment open repair
Clinical Study IdentifierNCT04986709
SponsorJOTEC GmbH
Last Modified on10 August 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients age is between 18 and 75 years
Patient is willing and able to comply with the standard follow-up visits planned after the implantation procedure
Patient is willing and able to give informed consent
Patient satisfies one of the following categories
Patient has acute / subacute aortic dissection and requires repair or replacement of damaged or diseased vessels of the aortic arch (with or without involvement of the ascending aorta), and the descending aorta requires treatment, or, in the opinion of the investigator, the patient would derive clinical benefit from prophylactic treatment of the descending aorta
Patient has chronic aortic dissection which requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta, and the patient satisfies one or more of the following criteria
Patient has aortic sinus, or ascending aorta, or aortic arch, or descending
aorta diameter 5.5 cm. Patient has aorta diameter < 5.5 cm and a growth rate
of 0.5 cm / year. Patient has ascending aorta diameter 4.5 cm and requires an
aortic valve repair or replacement. Patient has clinical signs of abdominal or
peripheral malperfusion
Patient has a fusiform or saccular aortic aneurysm which requires repair or
replacement of damaged or diseased vessels of the aortic arch and descending
aorta with or without involvement of the ascending aorta, and patient
satisfies the following criteria
Patient has a suitable distal sealing area in the descending thoracic aorta
proximal to the celiac trunk
And in case of fusiform aneurysm one of the following characteristics
Patient has aortic sinus, or ascending aorta, or aortic arch, or descending
aorta diameter 5.5 cm. Patient has aorta diameter < 5.5 cm and a growth rate
of 0.5 cm / year. Patient has ascending aorta diameter 4.5 cm and requires an
aortic valve repair or replacement
Patient is hemodynamically stable without pharmacological support at time of
admission to the hospital (stable blood pressure and heart rate, no shock)

Exclusion Criteria

Patient is unfit for open surgical repair involving circulatory arrest
Patient has known sensitivities or allergies to nitinol, polyester, platinumiridium, or polyethylene
Patient has systemic infection
Patient has endocarditis or active infection of the aorta
Patient has a free ruptured aorta
Patient has acute stroke or suspected acute stroke
Patient is on inotropes at time of arrival to the hospital
Patient needs mitral valve repair or replacement
Patient is enrolled or plans to be enrolled in another active study
Patient is pregnant or breastfeeding or planning to become pregnant during the course of the study
Patient has uncorrectable bleeding anomaly (i.e., thrombocytopenia)
Patient has an eGFR < 45 ml/min/1.73m2 before the intervention
Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated
Patient has co-morbidity (i.e. active malignancy (progressive, stable or partial remission)) causing expected survival to be less than 3 years
Patient has any other medical, social or psychological problems, that in the opinion of the investigator, preclude the patient from participating in this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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