A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)

NCT05954793 | Active Not Recruiting

• 1 other identifier: INNER-B-APAC
• Study Type: observational
• Target: 30
• Locations: 3 countries
• Sites: 8

Brief Summary

The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with thoracoabdominal aortic aneurysms.

Conditions

Thoracoabdominal Aortic Aneurysm

Keywords

aneurysm; thoracoabdominal; aortic; vascular; surgery

Outcome Measures

Primary Outcomes (1)

• Mortality

  Rate of all-cause mortality

  30 days

Secondary Outcomes (16)

• Mortality

  3-6 months, 12 months

• Rupture

  through study completion, an average of 12 months

• Major adverse events

  Prior to Discharge, 30 days, 3-6 months, 12 months

• Number of interventions

  Intra-Op

• Time E-nside delivery system remained in access vessels

  through study completion, an average of 12 months

Eligibility Criteria

• Age: 18 Years - 85 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 degenerative, atherosclerotic thoracoabdominal aortic aneurysm who are scheduled for implantation of an E-nside TAAA Multibranch Stent Graft at their physician's discretion and who are eligible in accordance with the criteria listed below.

You may qualify if:

• Patient is between 18 and 85 years old
• Patient has a degenerative, atherosclerotic thoracoabdominal aortic aneurysm
• Patient has adequate iliac/femoral access compatible with an 8.5 mm OD delivery system
• Patient's aorta has no distinct angulation in the thoracovisceral segment of the aorta ranging from 40 mm proximal to the celiac trunk to 20 mm distal to the lowest renal artery
• All target branch vessels are suitable for antegrade cannulation
• Diameter of the landing zone in each branch vessel to be treated is ≥ 5 mm
• Length of landing zone in each branch vessel to be treated is ≥ 15 mm (preferably ≥ 20 mm)
• Patient must be available for the appropriate follow-up times for the duration of the study
• Patient has signed the informed consent before implantation of the E-nside Stent Graft

You may not qualify if:

• Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
• Patient has systemic infection or suspected systemic infection
• Patient has an infectious aneurysm
• Patient has an inflammatory aneurysm
• Patient has a ruptured aneurysm
• Patient has a traumatic aneurysm
• Patient has a symptomatic aneurysm
• Patient has an aortic dissection
• Patient has a congenital degenerative collagen disease or connective tissue disorder
• Diameter of ostium of branch vessel to be treated \< 4 mm
• Patient has thrombocytopenia (platelet count \< 150000/μl)
• Patient has an eGFR \< 30 ml/min/1.73m2 before the intervention
• Patient has untreated hyperthyroidism
• Patient has a malignancy (progressive, stable or partial remission)
• Patient had a myocardial infarction or cerebrovascular accident \< 3 months ago

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (8)

Alfred Health

Melbourne, 3004, Australia

Location

Sir Charles Gairdner Hospital

Perth, 6009, Australia

Location

Royal North Shore Hospital

Saint Leonards, 2065, Australia

Location

Gold Coast University Hospital

Southport, 4215, Australia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Waikato Hospital Hamilton

Hamilton, 3204, New Zealand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Prince of Songkla University - Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 20, 2023
• Study Start: January 1, 2022
• Primary Completion: November 15, 2024
• Study Completion: February 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); TH (2); AU (4)