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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Aneurysm; Aortic Dissection
• Intervention / Treatment: Device: Open repair

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).

• Study Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1210
    • Klinikum Floridsdorf
• Germany
  • Essen, Germany, 45147
    • Westdeutsches Herzzentrum WHGZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	3-6, 12, 24, 36, 60 months
Mortality	Rate of aortic related mortality	30-day, 3-6, 12, 24, 36, 60 months
Major Adverse Events	Rate of patients who are free from Major Adverse Events (MAEs) (new permanent disabling stroke (mRS ≥ 2 and at baseline mRS < 2), new permanent (> 30 days) paraplegia or paraparesis, reintervention (excluding reoperation for bleeding or planned or unplanned additional intervention), all-cause mortality)	12 months
Device technical success	Rate of patients with device technical success	24 hours
Procedural success	Rate of patients with procedural success	At discharge, an avarage of 30 days
Treatment success	Rate of patients with treatment success	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Aortic rupture	Rate of patients with aortic rupture	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Additional intervention	Rate of patients with planned or unplanned additional intervention	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Reintervention	Rate of patients with reintervention	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Disabling stroke	Rate of patients with new disabling stroke	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Paraplegia	Rate of patients with new permanent (> 30 days) paraplegia	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Paraparesis	Rate of patients with new permanent (> 30 days) paraparesis	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Renal failure	Rate of patients with renal failure requiring permanent (> 90 days) dialysis or hemofiltration in a patient with a normal pre-procedure serum creatinine level	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Aortic regurgitation	Rate of patients with increase in aortic regurgitation grade of greater than 1 compared to pre-operative measurement	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Stenosis	Rate of patients with stenosis in the supra-aortic head vessels (0 - 30 %, >30 % - 50 %, > 50 % - 70%, > 70%)	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Patency	Rate of patients with patent supra-aortic head vessels	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Migration	Rate of patients with retrograde migration > 10 mm of the distal end of the stented part of E-vita OPEN NEO	3-6, 12, 24, 36, 60 months
Integrity	Rate of patients with failure of integrity of the E-vita OPEN NEO	At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months
Endoleak type Ib (aneurysm)	Rate of patients with aneurysm that have an endoleak type Ib	3-6, 12, 24, 36, 60 months
Endoleak type II (aneurysm)	Rate of patients with aneurysm that have an endoleak type II	3-6, 12, 24, 36, 60 months
Endoleak type III (aneurysm)	Rate of patients with aneurysm that have an endoleak type III	3-6, 12, 24, 36, 60 months
Endoleak type IV (aneurysm)	Rate of patients with aneurysm that have an endoleak type IV	3-6, 12, 24, 36, 60 months
Increasing aortic diameter	Rate of patients with aneurysm that have an increasing maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT	12, 24, 36, 60 months
Stable aortic diameter	Rate of patients with aneurysm that have a stable maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT	12, 24, 36, 60 months
Decreasing aortic diameter	Rate of patients with aneurysm that have a decreasing maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT	12, 24, 36, 60 months
Endoleak type Ib (dissection)	Rate of patients with dissection that have an endoleak type Ib	3-6, 12, 24, 36, 60 months
Endoleak II (dissection)	Rate of patients with dissection that have an endoleak type II	3-6, 12, 24, 36, 60 months
Endoleak type R (dissection)	Rate of patients with dissection that have an endoleak type R	3-6, 12, 24, 36, 60 months
Increasing or stable true lumen size	Rate of patients with increasing (≥ 5 mm) or stable true lumen in the stented region	3-6, 12, 24, 36, 60 months
Stable or decreasing false lumen size	Rate of patients with stable or decreasing (≤ - 5 mm) false lumen in the stented region	3-6, 12, 24, 36, 60 months
Obliterated false lumen in stented region	Rate of patients with obliterated false lumen in the stented region	3-6, 12, 24, 36, 60 months
Completely thrombosed false lumen in stented region	Rate of patients with completely thrombosed false lumen in the stented region	3-6, 12, 24, 36, 60 months
Partially thrombosed false lumen in stented region	Rate of patients with partially thrombosed false lumen in the stented region	3-6, 12, 24, 36, 60 months
Patent false lumen in stented region	Rate of patients with patent false lumen in the stented region	3-6, 12, 24, 36, 60 months
Obliterated false lumen between stent and celiac trunk	Rate of patients with obliterated false lumen between the bottom of the stent and the celiac trunk	3-6, 12, 24, 36, 60 months
Completely thrombosed false lumen between stent and celiac trunk	Rate of patients with completely thrombosed false lumen between the bottom of the stent and the celiac trunk	3-6, 12, 24, 36, 60 months
Patent false lumen between stent and celiac trunk	Rate of patients with patent false lumen between the bottom of the stent and the celiac trunk	3-6, 12, 24, 36, 60 months
Obliterated false lumen between celiac trunk and aortic bifurcation	Rate of patients with obliterated false lumen between the celiac trunk and the aortic bifurcation	3-6, 12, 24, 36, 60 months
Completely thrombosed false lumen between celiac trunk and aortic bifurcation	Rate of patients with completely thrombosed false lumen between the celiac trunk and the aortic bifurcation	3-6, 12, 24, 36, 60 months
Partially thrombosed false lumen between celiac trunk and aortic bifurcation	Rate of patients with partially thrombosed false lumen between the celiac trunk and the aortic bifurcation	3-6, 12, 24, 36, 60 months
Patent false lumen between celiac trunk and aortic bifurcation	Rate of patients with patent false lumen between the celiac trunk and the aortic bifurcation	3-6, 12, 24, 36, 60 months
Partially thrombosed false lumen between stent and celiac trunk	Rate of patients with partially thrombosed false lumen between the bottom of the stent and the celiac trunk	3-6, 12, 24, 36, 60 months

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Investigators: Principal Investigator: Martin Grabenwöger, Prof., Klinikum Floridsdorf

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Aorta; Trunk; Repair; Open; Thoracic; Aneuysm; Dissection; Frozen; Elephant
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aneurysm; Aortic Aneurysm; Aortic Dissection
• Other Study ID Numbers: NEOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No