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

February 12, 2026 updated by: JOTEC GmbH

INNER-B-APAC - Asian Pacific Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

In this study, patients will be observed who are planned to be treated an E-nside TAAA Multibranch Stent Graft System for endovascular repair of a degenerative, atherosclerotic thoracoabdominal aortic aneurysm. The E-nside TAAA Multibranch Stent Graft will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-nside TAAA Multibranch Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. Patient data will be documented in an eCRF at the following time points: Pre-operative planning, intervention(s), discharge(s) from hospital, 30 days, 3-6 and 12 months follow-up. The period of data collection will be approximately 12 months (depending on the time point of the 12 months FU visit) from the index procedure for each patient. A 100% source data verification will be performed regarding patient information and consent, criteria of patients to be documented, pre-operative planning, intervention(s), treatment results, adverse events, death, and reintervention. Complete DICOM image files of the CT scans will be sent to a CoreLab for independent second evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • Alfred Health
      • Perth, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Saint Leonards, Australia, 2065
        • Royal North Shore Hospital
      • Southport, Australia, 4215
        • Gold Coast University Hospital
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand, 3204
        • Waikato Hospital Hamilton
  • Thailand
      • Bangkok, Thailand
        • Siriraj Hospital
      • Songkhla, Thailand, 90110
        • Prince of Songkla University - Songklanagarind Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patient is planned to be treated with a chimney in the left subclavian artery
  • Patient has had a previous surgical repair of descending thoracic aorta
  • Patient will be treated or had been treated with a Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) or Anaconda (Vascutek) stent graft
  • Patient is enrolled or plans to be enrolled in another clinical study
  • Patient is pregnant or breastfeeding or planning to become pregnant during the course of the study.
  • Patient has a life expectancy of less than 3 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Rate of all-cause mortality
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 3-6 months, 12 months
Rate of all-cause mortality
3-6 months, 12 months
Rupture
Time Frame: through study completion, an average of 12 months
Rate of patients with aneurysm rupture
through study completion, an average of 12 months
Major adverse events
Time Frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Rate of patients with major adverse events
Prior to Discharge, 30 days, 3-6 months, 12 months
Number of interventions
Time Frame: Intra-Op
Rate of interventions in peri-operative periods
Intra-Op
Time E-nside delivery system remained in access vessels
Time Frame: through study completion, an average of 12 months
Rate of time intervals the E-nside delivery system remained in the access vessels in relation to the number of branches treated with pre-cannulation
through study completion, an average of 12 months
Reinterventions
Time Frame: 30 days, 3-6, 12 months
Rate of reinterventions
30 days, 3-6, 12 months
Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin
Time Frame: 12 months
Rate of patients with type Ia, Ib, Ic endoleak (at 12 months follow-up)
12 months
Intercomponent separation
Time Frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Rate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft > 10 mm
Prior to Discharge, 30 days, 3-6 months, 12 months
Loss of device integrity
Time Frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)
Prior to Discharge, 30 days, 3-6 months, 12 months
Kinking of E-nside Stent Graft or bridging stents
Time Frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Rate of patients with E-nside stent graft or bridging stent kinking
Prior to Discharge, 30 days, 3-6 months, 12 months
Primary and secondary patency (overall and separately for each type of branch)
Time Frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Rate of primary/secondary patency of bridging stents Rate of primary/secondary patency of the bridging stent of the celiac trunk Rate of primary/secondary patency of the bridging stent of the superior mesenteric artery Rate of primary/secondary patency of the bridging stent of the right renal artery Rate of primary/secondary patency of the bridging stent of the left renal artery Rate of primary/secondary patency of branch vessels treated
Prior to Discharge, 30 days, 3-6 months, 12 months
Stent graft infection
Time Frame: through study completion, an average of 12 months
Rate of patients with stent graft infection
through study completion, an average of 12 months
Primary and secondary technical success
Time Frame: 24 hours
Rate of patients with primary/secondary technical success
24 hours
Primary and secondary clinical success
Time Frame: 12 months
Rate of patients with primary/secondary clinical success
12 months
Stable, decreasing or increasing aneurysm size
Time Frame: 12 months
Rate of patients with stable, decreasing or increasing aneurysm size
12 months
Removal or failure to implant the stent graft
Time Frame: through study completion, an average of 12 months
Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft
through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JOTEC GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INNER-B-APAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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