Thoracoabdominal Aortic AneurysmNCT05954793

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

An observational study of Thoracoabdominal Aortic Aneurysm, run by JOTEC GmbH at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Thoracoabdominal Aortic Aneurysm
How many people: 16 participants
Where: 8 sitesin 3 countries
Study dates: 1 Jan 2022to 8 Sep 2026
How long will I take part?: 1 Year
Phase: Observational
Are there results?: None posted in the registry

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 85 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 21Show fewer

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

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Australia4 sites

Alfred Health
Melbourne, 3004
Sir Charles Gairdner Hospital
Perth, 6009
Royal North Shore Hospital
Saint Leonards, 2065
Gold Coast University Hospital
Southport, 4215

Other trials in Australia

New Zealand2 sites

Auckland City Hospital
Auckland, 1023
Waikato Hospital Hamilton
Hamilton, 3204

Other trials in New Zealand

Thailand2 sites

Siriraj Hospital
Bangkok
Prince of Songkla University - Songklanagarind Hospital
Songkhla, 90110

Other trials in Thailand

About this study

Official title: 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

Read the 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.

Conditions: Thoracoabdominal Aortic Aneurysm
Keywords: aneurysm, thoracoabdominal, aortic, vascular, surgery
Medical subject headings: Aortic Aneurysm, Thoracoabdominal, Aneurysm

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 days

Secondary outcomes (16)

Mortality
Rate of all-cause mortality
Measured: 3-6 months, 12 months
Rupture
Rate of patients with aneurysm rupture
Measured: through study completion, an average of 12 months
Major adverse events
Rate of patients with major adverse events
Measured: Prior to Discharge, 30 days, 3-6 months, 12 months
Number of interventions
Rate of interventions in peri-operative periods
Measured: Intra-Op
Time E-nside delivery system remained in access vessels
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
Measured: through study completion, an average of 12 months
Reinterventions
Rate of reinterventions
Measured: 30 days, 3-6, 12 months
Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin
Rate of patients with type Ia, Ib, Ic endoleak (at 12 months follow-up)
Measured: 12 months
Intercomponent separation
Rate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft > 10 mm
Measured: Prior to Discharge, 30 days, 3-6 months, 12 months
Loss of device integrity
Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)
Measured: Prior to Discharge, 30 days, 3-6 months, 12 months
Kinking of E-nside Stent Graft or bridging stents
Rate of patients with E-nside stent graft or bridging stent kinking
Measured: Prior to Discharge, 30 days, 3-6 months, 12 months
Primary and secondary patency (overall and separately for each type of branch)
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
Measured: Prior to Discharge, 30 days, 3-6 months, 12 months
Stent graft infection
Rate of patients with stent graft infection
Measured: through study completion, an average of 12 months
Primary and secondary technical success
Rate of patients with primary/secondary technical success
Measured: 24 hours
Primary and secondary clinical success
Rate of patients with primary/secondary clinical success
Measured: 12 months
Stable, decreasing or increasing aneurysm size
Rate of patients with stable, decreasing or increasing aneurysm size
Measured: 12 months
Removal or failure to implant the stent graft
Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft
Measured: through study completion, an average of 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20228 Sep 2026

First posted20 Jul 2023
Study start1 Jan 2022
Primary completion15 Nov 2024
Study completion8 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Thoracoabdominal Aortic AneurysmStudies 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: 16 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT05954793
Sponsor's protocol ID: INNER-B-APAC
Status last verified: Oct 2026
First submitted: 23 Jun 2023
Last updated: 29 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Recruiting
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Thoracoabdominal Aortic Aneurysm, Endovascular Repair

All Thoracoabdominal Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05954793
Acronym / sponsor ID: INNER-B-APAC
Conditions: Thoracoabdominal Aortic Aneurysm
Keywords: aneurysm, thoracoabdominal, aortic, vascular, surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: JOTEC GmbHIndustry (pharma, biotech, devices)
Study start: 1 Jan 2022 (actual)
Primary completion: 15 Nov 2024 (actual)
Study completion: 8 Sep 2026 (actual)
First posted: 20 Jul 2023 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (9 listed)

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

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Mortality
Time frame: 30 days
Rate of all-cause mortality

16 secondary outcomes

Mortality
Time frame: 3-6 months, 12 months
Rupture
Time frame: through study completion, an average of 12 months
Major adverse events
Time frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Number of interventions
Time frame: Intra-Op
Time E-nside delivery system remained in access vessels
Time frame: through study completion, an average of 12 months
Reinterventions
Time frame: 30 days, 3-6, 12 months
Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin
Time frame: 12 months
Intercomponent separation
Time frame: 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
Kinking of E-nside Stent Graft or bridging stents
Time frame: 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
Stent graft infection
Time frame: through study completion, an average of 12 months
Primary and secondary technical success
Time frame: 24 hours
Primary and secondary clinical success
Time frame: 12 months
Stable, decreasing or increasing aneurysm size
Time frame: 12 months
Removal or failure to implant the stent graft
Time frame: through study completion, an average of 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Thoracoabdominal Aortic Aneurysm

RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Recruiting
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Thoracoabdominal Aortic Aneurysm, Endovascular Repair

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.

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracoabdominal Aortic Aneurysm, run by JOTEC GmbH at 8 sites in 3 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Australia, New Zealand, Thailand. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05954793.

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 29 Oct 2026.