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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Aortic Dissection, Aortic Aneurysm

Intervention / Treatment
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* Device: Open repair


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Open repair|Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.|

What is the study measuring?
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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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic, Aorta, Aneuysm, Dissection, Open, Repair, Frozen, Elephant, Trunk