An observational study in Thoracoabdominal Aortic Aneurysm, sponsored by JOTEC GmbH. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by JOTEC GmbH · Observational
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.
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.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's enrollment of 16 is below the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →JOTEC GmbH is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mortality
Rate of all-cause mortality
Time frame: 30 days
Mortality
Rate of all-cause mortality
Time frame: 3-6 months, 12 months
Rupture
Rate of patients with aneurysm rupture
Time frame: through study completion, an average of 12 months
Major adverse events
Rate of patients with major adverse events
Time frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Number of interventions
Rate of interventions in peri-operative periods
Time frame: 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
Time frame: through study completion, an average of 12 months
Reinterventions
Rate of reinterventions
Time frame: 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)
Time frame: 12 months
Intercomponent separation
Rate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft \> 10 mm
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Prior to Discharge, 30 days, 3-6 months, 12 months
Stent graft infection
Rate of patients with stent graft infection
Time frame: through study completion, an average of 12 months
Primary and secondary technical success
Rate of patients with primary/secondary technical success
Time frame: 24 hours
Primary and secondary clinical success
Rate of patients with primary/secondary clinical success
Time frame: 12 months
Stable, decreasing or increasing aneurysm size
Rate of patients with stable, decreasing or increasing aneurysm size
Time frame: 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
Time frame: through study completion, an average of 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Nov 2024, 34 months.
Completion moved once since we started tracking on Sep 25, 2026: Feb 2026 → Sep 2026, on Oct 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Aortic Aneurysm, Thoracoabdominal →
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