Clinical trial NCT04676672: A PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
Official title: NEOS - A Post-market Clinical Follow-up Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Dissection
Aortic Aneurysm
Keywords: Thoracic
Aorta
Aneuysm
Dissection
Open
Repair
Frozen
Elephant
Trunk
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients with thoracic aortic dissection or aneurysm who are eligible for surgical treatment with the frozen elephant trunk technique according to the instructions for use for E-vita OPEN NEO and scheduled for implantation of E-vita OPEN NEO at their physician's discretion in accordance with the inclusion and exclusion criteria.

Brief summary: The NEOS 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.

Detailed 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 60 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. All adverse events defined prior to study start will be adjudicated by the Clinical Event Committee (CEC).

Eligibility criteria: Inclusion Criteria:

* Patient´s 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, platinum-iridium, 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.

Primary outcomes:
measure: Mortality
timeFrame: 30-day
Secondary outcomes:
measure: Mortality
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Mortality
timeFrame: 30-day, 3-6, 12, 24, 36, 60 months
measure: Major Adverse Events
timeFrame: 12 months
measure: Device technical success
timeFrame: 24 hours
measure: Procedural success
timeFrame: At discharge, an avarage of 30 days
measure: Treatment success
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Aortic rupture
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Additional intervention
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Reintervention
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Disabling stroke
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Paraplegia
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Paraparesis
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Renal failure
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Aortic regurgitation
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Stenosis
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Patency
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Migration
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Integrity
timeFrame: At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
measure: Endoleak type Ib (aneurysm)
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Endoleak type II (aneurysm)
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Endoleak type III (aneurysm)
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Endoleak type IV (aneurysm)
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Increasing aortic diameter
timeFrame: 12, 24, 36, 60 months
measure: Stable aortic diameter
timeFrame: 12, 24, 36, 60 months
measure: Decreasing aortic diameter
timeFrame: 12, 24, 36, 60 months
measure: Endoleak type Ib (dissection)
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Endoleak II (dissection)
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Endoleak type R (dissection)
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Increasing or stable true lumen size
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Stable or decreasing false lumen size
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Obliterated false lumen in stented region
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Completely thrombosed false lumen in stented region
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Partially thrombosed false lumen in stented region
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Patent false lumen in stented region
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Obliterated false lumen between stent and celiac trunk
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Completely thrombosed false lumen between stent and celiac trunk
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Partially thrombosed false lumen between stent and celiac trunk
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Patent false lumen between stent and celiac trunk
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Obliterated false lumen between celiac trunk and aortic bifurcation
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Completely thrombosed false lumen between celiac trunk and aortic bifurcation
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Partially thrombosed false lumen between celiac trunk and aortic bifurcation
timeFrame: 3-6, 12, 24, 36, 60 months
measure: Patent false lumen between celiac trunk and aortic bifurcation
timeFrame: 3-6, 12, 24, 36, 60 months
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Klinikum Floridsdorf
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum WHGZ
Study officials:
affiliation: Klinikum Floridsdorf
name: Martin Grabenwöger, Prof.
role: PRINCIPAL_INVESTIGATOR
References: