An observational study in Vascular Aneurysm, sponsored by JOTEC GmbH. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by JOTEC GmbH · Observational
The INNER-B post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a thoracoabdominal aneurysm when treated by the E-nside TAAA Multibranch Stent Graft System.
The secondary objective is to evaluate the safety and clinical performance of the device.
In this study patients will be observed, who receive an E-nside TAAA Multibranch Stent Graft System for the endovascular treatment 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.
The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.
381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.
This study's planned enrollment of 150 is close to the median of 157 across 132 observational studies indexed under Aneurysm.
Browse Aneurysm 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 inclusion / exclusion criteria.
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.
Endovascular repair of thoracoabdominal aneurysm using stent grafts.
Mortality
Rate of all-cause mortality
Time frame: 30-day
Mortality
Rate of all-cause mortality in peri-operative periods (all related interventions)
Time frame: 24 hours
Mortality
Rate of all-cause mortality
Time frame: 3-6, 12, 24, 36, 60 months
Rupture
Rate of patients with aneurysm rupture
Time frame: 30-day, 3-6, 12, 24, 36, 60 months
Major Adverse Events (MAE)
Rate of patients with major adverse events (aneurysm related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, visceral ischemia (bowel ischemia with surgery or submission to ICU or bowel necrosis with surgery or submission to ICU), new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, new permanent paraplegia, new permanent paraparesis, lower limb ischemia (increase in Rutherford classification) (product-related, procedure-related, aneurysm-related)
Time frame: prior to discharge, 30 days, 3-6, 12, 24, 36, 60 months
Number of intervention(s)
Rate of interventions in peri-operative periods (all related interventions until index procedure)
Time frame: perioperative
Delivery time
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: perioperative
Reintervention
Rate of reintervention(s)
Time frame: 30 days, 3-6, 12, 24, 36, 60 months
Endoleak Type Ia
Rate of patients with type Ia endoleak
Time frame: 12, 24, 36, 60 months
Endoleak Type Ib
Rate of patients with type Ib endoleak
Time frame: 12, 24, 36, 60 months
Endoleak Type Ic
Rate of patients with type Ic endoleak
Time frame: 12, 24, 36, 60 months
Endoleak Type II
Rate of patients with type II endoleak
Time frame: 12, 24, 36, 60 months
Endoleak Type III
Rate of patients with type III endoleak
Time frame: 12, 24, 36, 60 months
Endoleak Type IV
Rate of patients with type IV endoleak
Time frame: 12, 24, 36, 60 months
Endoleak of unknown origin
Rate of patients with endoleak of unknown origin
Time frame: 12, 24, 36, 60 months
Proximal intercomponent separation
Rate of patients with intercomponent separation at the proximal end of the E-nside stent graft \> 10 mm
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Distal intercomponent separation
Rate of patients with intercomponent separation at the distal end of the E-nside stent graft \> 10 mm
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
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, 12, 24, 36, 60 months
Kinking
Rate of patients with E-nside stent graft or bridging stent graft kinking
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency
Rate of primary patency of bridging stents
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the celiac trunk
Rate of primary patency of the bridging stent of the celiac trunk
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the superior mesenteric artery
Rate of primary patency of the bridging stent of the superior mesenteric artery
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the right renal artery
Rate of primary patency of the bridging stent of the right renal artery
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of bridging stent of the left renal artery
Rate of primary patency of the bridging stent of the left renal artery
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency
Rate of secondary patency of bridging stents
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the celiac trunk
Rate of secondary patency of the bridging stent of the celiac trunk
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the superior mesenteric artery
Rate of secondary patency of the bridging stent of the superior mesenteric artery
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the right renal artery
Rate of secondary patency of the bridging stent of the right renal artery
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency of the bridging stent of the left renal artery
Rate of secondary patency of the bridging stent of the left renal artery
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Infection
Rate of patients with stent graft infection
Time frame: 30-day, 12, 24, 36, 60 months
Primary technical success
Rate of patients with primary technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated within 24 h after the index procedure. Successful introduction and deployment of the E-nside TAAA Multibranch Stent Graft in the absence of: Surgical conversion Mortality Reintervention Unplanned branch vessel occlusion (post-operative occlusion) Including: Secure proximal and distal fixation Patent treated branch vessels
Time frame: 24 hours
Technical success
Rate of patients with technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.
Time frame: 24 hours
Primary clinical success
Rate of patients with primary clinical success. Primary clinical success is reported on an intent-to-treat basis and is reached if the following criteria are fulfilled at the time of follow-up starting at 12 months follow-up: Successful deployment of the endovascular devices at the intended location in the absence of: Death as result of aneurysm-related treatment Conversion to open repair Reintervention after index procedure Occlusion of treated branch vessels Type I or III endoleak Increasing aneurysm size Aneurysm rupture
Time frame: 12, 24, 36, 60 months
Clinical success
Rate of patients with clinical success. Clinical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.
Time frame: 12, 24, 36, 60 months
Stable aneurysm size
Rate of patients with stable aneurysm size
Time frame: 12, 24, 36, 60 months
Decreasing (< 5 mm) aneurysm size
Rate of patients with decreasing aneurysm size
Time frame: 12, 24, 36, 60 months
Increasing (> 5 mm) aneurysm size
Rate of patients with increasing aneurysm size
Time frame: 12, 24, 36, 60 months
Stent graft removal
Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft
Time frame: 24 hours, prior to discharge/30 days, 12, 24, 36, 60 months
Ran from Jul 2020 to primary completion in Feb 2025, 54 months.
Of 41 industry-sponsored observational studies under Aneurysm, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 61. This study's 54 months is above that.
Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 33 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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JOTEC GmbH