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

Active, not recruiting

• Conditions: Aortic Dissection; Aortic Aneurysm

• Registration Number: NCT04676672
• Lead Sponsor: JOTEC GmbH

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).

Study Timeline

• Study Start: 2020-12-03
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-21
• Primary Completion: 2023-07-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 163

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	30-day	Rate of all-cause mortality

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Klinikum Floridsdorf; 🇦🇹 Wien, Austria

Westdeutsches Herzzentrum WHGZ; 🇩🇪 Essen, Germany