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

NCT04986709 | Active Not Recruiting

• 1 other identifier: NEOS-APAC
• Study Type: observational
• Target: 114
• Locations: 6 countries
• Sites: 10

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.

Conditions

Aortic Dissection; Aortic Aneurysm

Keywords

Thoracic; Aorta; Aneuysm; Dissection; Open; Repair; Frozen; Elephant; Trunk

Outcome Measures

Primary Outcomes (1)

• Mortality

  Rate of all-cause mortality

  30-day

Secondary Outcomes (42)

• Mortality

  3-6, 12, 24 months

• Mortality

  30-day, 3-6, 12, 24 months

• Major Adverse Events

  12 months

• Device technical success

  24 hours

• Procedural success

  At discharge, an avarage of 30 days

Interventions

Open repair DEVICE

Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (10)

Austin Health

Heidelberg, Victoria, Australia

Location

Prince of Wales Hospital (PWH)

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital II

Kota Kinabalu, Malaysia

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

National University Hospital

Singapore, Singapore

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Ewha Womans University Seoul Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Aortic Dissection; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 3, 2021
• Study Start: August 1, 2021
• Primary Completion: October 31, 2024
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2); SG (1); TH (1); AU (1); KR (3); MY (2)