Aortic DissectionNEOS-APACNCT04986709
PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
An observational study of Aortic Dissection and Aortic Aneurysm, run by JOTEC GmbH at 10 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aortic Dissection, Aortic Aneurysm
- What is being tested?
- Open repair
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 1 Aug 2021to 31 Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 12Show fewer
- 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).
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam
Ewha Womans University Seoul Hospital
Seoul
Gangnam Severance Hospital
Seoul
Hong Kong2 sites
Prince of Wales Hospital (PWH)
Hong Kong
Queen Mary Hospital
Hong Kong
Malaysia2 sites
Queen Elizabeth Hospital II
Kota Kinabalu
Institut Jantung Negara
Kuala Lumpur
About this study
Official title: NEOS-APAC - Asian Pacific 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-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.
Read the 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 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.
- Conditions
- Aortic Dissection, Aortic Aneurysm
- Being tested
- Open repair
- Keywords
- Thoracic, Aorta, Aneuysm, Dissection, Open, Repair, Frozen, Elephant, Trunk
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open repairDevice
Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of all-cause mortality
Measured: 30-day
Secondary outcomes (42)
Mortality
Rate of all-cause mortality
Measured: 3-6, 12, 24 months
Mortality
Rate of aortic related mortality
Measured: 30-day, 3-6, 12, 24 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)
Measured: 12 months
Device technical success
Rate of patients with device technical success
Measured: 24 hours
Procedural success
Rate of patients with procedural success
Measured: At discharge, an avarage of 30 days
Treatment success
Rate of patients with treatment success
Measured: At discharge, an avarage of 30 days, 3-6,12, 24 months
Aortic rupture
Rate of patients with aortic rupture
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Additional intervention
Rate of patients with planned or unplanned additional intervention
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Reintervention
Rate of patients with reintervention
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Disabling stroke
Rate of patients with new disabling stroke
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Paraplegia
Rate of patients with new permanent (> 30 days) paraplegia
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Paraparesis
Rate of patients with new permanent (> 30 days) paraparesis
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 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
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Aortic regurgitation
Rate of patients with increase in aortic regurgitation grade of greater than 1 compared to pre-operative measurement
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Stenosis
Rate of patients with stenosis in the supra-aortic head vessels (0 - 30 %, >30 % - 50 %, > 50 % - 70%, > 70%)
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Patency
Rate of patients with patent supra-aortic head vessels
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Migration
Rate of patients with retrograde migration > 10 mm of the distal end of the stented part of E-vita OPEN NEO
Measured: 3-6, 12, 24 months
Integrity
Rate of patients with failure of integrity of the E-vita OPEN NEO
Measured: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Endoleak type Ib (aneurysm)
Rate of patients with aneurysm that have an endoleak type Ib
Measured: 3-6, 12, 24 months
Endoleak type II (aneurysm)
Rate of patients with aneurysm that have an endoleak type II
Measured: 3-6, 12, 24 months
Endoleak type III (aneurysm)
Rate of patients with aneurysm that have an endoleak type III
Measured: 3-6, 12, 24 months
Endoleak type IV (aneurysm)
Rate of patients with aneurysm that have an endoleak type IV
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 months
Endoleak type Ib (dissection)
Rate of patients with dissection that have an endoleak type Ib
Measured: 3-6, 12, 24 months
Endoleak II (dissection)
Rate of patients with dissection that have an endoleak type II
Measured: 3-6, 12, 24 months
Endoleak type R (dissection)
Rate of patients with dissection that have an endoleak type R
Measured: 3-6, 12, 24 months
Increasing or stable true lumen size
Rate of patients with increasing (≥ 5 mm) or stable true lumen in the stented region
Measured: 3-6, 12, 24 months
Stable or decreasing false lumen size
Rate of patients with stable or decreasing (≤ - 5 mm) false lumen in the stented region
Measured: 3-6, 12, 24 months
Obliterated false lumen in stented region
Rate of patients with obliterated false lumen in the stented region
Measured: 3-6, 12, 24 months
Completely thrombosed false lumen in stented region
Rate of patients with completely thrombosed false lumen in the stented region
Measured: 3-6, 12, 24 months
Partially thrombosed false lumen in stented region
Rate of patients with partially thrombosed false lumen in the stented region
Measured: 3-6, 12, 24 months
Patent false lumen in stented region
Rate of patients with patent false lumen in the stented region
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: Time Frame: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 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
Measured: 3-6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Aug 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986709
- Sponsor's protocol ID
- NEOS-APAC
- Acronym
- NEOS-APAC
- Status last verified
- Feb 2024
- First submitted
- 21 Jul 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOS-APAC - Asian Pacific Post-market Clinical Follow-up Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
- ClinicalTrials.gov ID
- NCT04986709
- Acronym / sponsor ID
- NEOS-APAC / NEOS-APAC
- Conditions
- Aortic Dissection, Aortic Aneurysm
- Keywords
- Thoracic, Aorta, Aneuysm, Dissection, Open, Repair, Frozen, Elephant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open repairOpen repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft. | Device | – |
Primary outcome
Mortality
Time frame: 30-day
Rate of all-cause mortality
42 secondary outcomes
Mortality
Time frame: 3-6, 12, 24 months
Mortality
Time frame: 30-day, 3-6, 12, 24 months
Major Adverse Events
Time frame: 12 months
Device technical success
Time frame: 24 hours
Procedural success
Time frame: At discharge, an avarage of 30 days
Treatment success
Time frame: At discharge, an avarage of 30 days, 3-6,12, 24 months
Aortic rupture
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Additional intervention
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Reintervention
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Disabling stroke
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Paraplegia
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Paraparesis
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Renal failure
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Aortic regurgitation
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Stenosis
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Patency
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Migration
Time frame: 3-6, 12, 24 months
Integrity
Time frame: At discharge, an avarage of 30 days, 3-6, 12, 24 months
Endoleak type Ib (aneurysm)
Time frame: 3-6, 12, 24 months
Endoleak type II (aneurysm)
Time frame: 3-6, 12, 24 months
Endoleak type III (aneurysm)
Time frame: 3-6, 12, 24 months
Endoleak type IV (aneurysm)
Time frame: 3-6, 12, 24 months
Increasing aortic diameter
Time frame: 3-6, 12, 24 months
Stable aortic diameter
Time frame: 3-6, 12, 24 months
Decreasing aortic diameter
Time frame: 3-6, 12, 24 months
Endoleak type Ib (dissection)
Time frame: 3-6, 12, 24 months
Endoleak II (dissection)
Time frame: 3-6, 12, 24 months
Endoleak type R (dissection)
Time frame: 3-6, 12, 24 months
Increasing or stable true lumen size
Time frame: 3-6, 12, 24 months
Stable or decreasing false lumen size
Time frame: 3-6, 12, 24 months
Obliterated false lumen in stented region
Time frame: 3-6, 12, 24 months
Completely thrombosed false lumen in stented region
Time frame: 3-6, 12, 24 months
Partially thrombosed false lumen in stented region
Time frame: 3-6, 12, 24 months
Patent false lumen in stented region
Time frame: 3-6, 12, 24 months
Obliterated false lumen between stent and celiac trunk
Time frame: 3-6, 12, 24 months
Completely thrombosed false lumen between stent and celiac trunk
Time frame: 3-6, 12, 24 months
Partially thrombosed false lumen between stent and celiac trunk
Time frame: Time Frame: 3-6, 12, 24 months
Patent false lumen between stent and celiac trunk
Time frame: 3-6, 12, 24 months
Obliterated false lumen between celiac trunk and aortic bifurcation
Time frame: 3-6, 12, 24 months
Completely thrombosed false lumen between celiac trunk and aortic bifurcation
Time frame: 3-6, 12, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection and Aortic Aneurysm, run by JOTEC GmbH at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea, Hong Kong, Malaysia, Australia, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.