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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04986709




Registration number
NCT04986709
Ethics application status
Date submitted
21/07/2021
Date registered
3/08/2021
Date last updated
8/02/2024

Titles & IDs
Public title
PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
Scientific 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
Secondary ID [1] 0 0
NEOS-APAC
Universal Trial Number (UTN)
Trial acronym
NEOS-APAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Dissection 0 0
Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Open repair

Treatment: Devices: Open repair
Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
30-day
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
3-6, 12, 24 months
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
30-day, 3-6, 12, 24 months
Secondary outcome [3] 0 0
Major Adverse Events
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Device technical success
Timepoint [4] 0 0
24 hours
Secondary outcome [5] 0 0
Procedural success
Timepoint [5] 0 0
At discharge, an avarage of 30 days
Secondary outcome [6] 0 0
Treatment success
Timepoint [6] 0 0
At discharge, an avarage of 30 days, 3-6,12, 24 months
Secondary outcome [7] 0 0
Aortic rupture
Timepoint [7] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [8] 0 0
Additional intervention
Timepoint [8] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [9] 0 0
Reintervention
Timepoint [9] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [10] 0 0
Disabling stroke
Timepoint [10] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [11] 0 0
Paraplegia
Timepoint [11] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [12] 0 0
Paraparesis
Timepoint [12] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [13] 0 0
Renal failure
Timepoint [13] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [14] 0 0
Aortic regurgitation
Timepoint [14] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [15] 0 0
Stenosis
Timepoint [15] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [16] 0 0
Patency
Timepoint [16] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [17] 0 0
Migration
Timepoint [17] 0 0
3-6, 12, 24 months
Secondary outcome [18] 0 0
Integrity
Timepoint [18] 0 0
At discharge, an avarage of 30 days, 3-6, 12, 24 months
Secondary outcome [19] 0 0
Endoleak type Ib (aneurysm)
Timepoint [19] 0 0
3-6, 12, 24 months
Secondary outcome [20] 0 0
Endoleak type II (aneurysm)
Timepoint [20] 0 0
3-6, 12, 24 months
Secondary outcome [21] 0 0
Endoleak type III (aneurysm)
Timepoint [21] 0 0
3-6, 12, 24 months
Secondary outcome [22] 0 0
Endoleak type IV (aneurysm)
Timepoint [22] 0 0
3-6, 12, 24 months
Secondary outcome [23] 0 0
Increasing aortic diameter
Timepoint [23] 0 0
3-6, 12, 24 months
Secondary outcome [24] 0 0
Stable aortic diameter
Timepoint [24] 0 0
3-6, 12, 24 months
Secondary outcome [25] 0 0
Decreasing aortic diameter
Timepoint [25] 0 0
3-6, 12, 24 months
Secondary outcome [26] 0 0
Endoleak type Ib (dissection)
Timepoint [26] 0 0
3-6, 12, 24 months
Secondary outcome [27] 0 0
Endoleak II (dissection)
Timepoint [27] 0 0
3-6, 12, 24 months
Secondary outcome [28] 0 0
Endoleak type R (dissection)
Timepoint [28] 0 0
3-6, 12, 24 months
Secondary outcome [29] 0 0
Increasing or stable true lumen size
Timepoint [29] 0 0
3-6, 12, 24 months
Secondary outcome [30] 0 0
Stable or decreasing false lumen size
Timepoint [30] 0 0
3-6, 12, 24 months
Secondary outcome [31] 0 0
Obliterated false lumen in stented region
Timepoint [31] 0 0
3-6, 12, 24 months
Secondary outcome [32] 0 0
Completely thrombosed false lumen in stented region
Timepoint [32] 0 0
3-6, 12, 24 months
Secondary outcome [33] 0 0
Partially thrombosed false lumen in stented region
Timepoint [33] 0 0
3-6, 12, 24 months
Secondary outcome [34] 0 0
Patent false lumen in stented region
Timepoint [34] 0 0
3-6, 12, 24 months
Secondary outcome [35] 0 0
Obliterated false lumen between stent and celiac trunk
Timepoint [35] 0 0
3-6, 12, 24 months
Secondary outcome [36] 0 0
Completely thrombosed false lumen between stent and celiac trunk
Timepoint [36] 0 0
3-6, 12, 24 months
Secondary outcome [37] 0 0
Partially thrombosed false lumen between stent and celiac trunk
Timepoint [37] 0 0
Time Frame: 3-6, 12, 24 months
Secondary outcome [38] 0 0
Patent false lumen between stent and celiac trunk
Timepoint [38] 0 0
3-6, 12, 24 months
Secondary outcome [39] 0 0
Obliterated false lumen between celiac trunk and aortic bifurcation
Timepoint [39] 0 0
3-6, 12, 24 months
Secondary outcome [40] 0 0
Completely thrombosed false lumen between celiac trunk and aortic bifurcation
Timepoint [40] 0 0
3-6, 12, 24 months
Secondary outcome [41] 0 0
Partially thrombosed false lumen between celiac trunk and aortic bifurcation
Timepoint [41] 0 0
3-6, 12, 24 months
Secondary outcome [42] 0 0
Patent false lumen between celiac trunk and aortic bifurcation
Timepoint [42] 0 0
3-6, 12, 24 months

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seongnam
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Malaysia
State/province [4] 0 0
Kota Kinabalu
Country [5] 0 0
Malaysia
State/province [5] 0 0
Kuala Lumpur
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore
Country [7] 0 0
Thailand
State/province [7] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
JOTEC GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04986709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04986709