Vascular AneurysmINNER-BNCT04383145
A Study in Patients With Thoracoabdominal Aortic Aneurysm Treated With the E-nside TAAA Multibranch Stent Graft System
An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vascular Aneurysm
- What is being tested?
- endovascular repair
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2020to 28 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 inclusion / exclusion criteria.
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 enrolment
- Patient has untreated hyperthyroidism
- Patient has a malignancy (progressive, stable or partial remission) with less than one-year projected survival
- 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
1 site in 1 country.
About this study
Official title: INNER-B - A Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System
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.
Read the detailed description
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.
- Conditions
- Vascular Aneurysm
- Being tested
- endovascular repair
- Keywords
- Thoracoabdominal, aorta, aneurysm, endovascular, repair
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular repairDevice
Endovascular repair of thoracoabdominal aneurysm using stent grafts.
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-day
Secondary outcomes (37)
Mortality
Rate of all-cause mortality in peri-operative periods (all related interventions)
Measured: 24 hours
Mortality
Rate of all-cause mortality
Measured: 3-6, 12, 24, 36, 60 months
Rupture
Rate of patients with aneurysm rupture
Measured: 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)
Measured: 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)
Measured: 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
Measured: perioperative
Reintervention
Rate of reintervention(s)
Measured: 30 days, 3-6, 12, 24, 36, 60 months
Endoleak Type Ia
Rate of patients with type Ia endoleak
Measured: 12, 24, 36, 60 months
Endoleak Type Ib
Rate of patients with type Ib endoleak
Measured: 12, 24, 36, 60 months
Endoleak Type Ic
Rate of patients with type Ic endoleak
Measured: 12, 24, 36, 60 months
Endoleak Type II
Rate of patients with type II endoleak
Measured: 12, 24, 36, 60 months
Endoleak Type III
Rate of patients with type III endoleak
Measured: 12, 24, 36, 60 months
Endoleak Type IV
Rate of patients with type IV endoleak
Measured: 12, 24, 36, 60 months
Endoleak of unknown origin
Rate of patients with endoleak of unknown origin
Measured: 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
Measured: 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
Measured: 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)
Measured: prior to discharge/30 days, 12, 24, 36, 60 months
Kinking
Rate of patients with E-nside stent graft or bridging stent graft kinking
Measured: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency
Rate of primary patency of bridging stents
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency
Rate of secondary patency of bridging stents
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: prior to discharge/30 days, 12, 24, 36, 60 months
Infection
Rate of patients with stent graft infection
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12, 24, 36, 60 months
Stable aneurysm size
Rate of patients with stable aneurysm size
Measured: 12, 24, 36, 60 months
Decreasing (< 5 mm) aneurysm size
Rate of patients with decreasing aneurysm size
Measured: 12, 24, 36, 60 months
Increasing (> 5 mm) aneurysm size
Rate of patients with increasing aneurysm size
Measured: 12, 24, 36, 60 months
Stent graft removal
Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft
Measured: 24 hours, prior to discharge/30 days, 12, 24, 36, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 Jul 2020
- Primary completion1 Feb 2025
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AneurysmStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dittmar Böckler, Prof. Dr., Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383145
- Sponsor's protocol ID
- INNER-B
- Acronym
- INNER-B
- Status last verified
- Feb 2026
- First submitted
- 3 May 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INNER-B - A Post-market Clinical Follow-up Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System
- ClinicalTrials.gov ID
- NCT04383145
- Acronym / sponsor ID
- INNER-B / INNER-B
- Conditions
- Vascular Aneurysm
- Keywords
- Thoracoabdominal, aorta, aneurysm, endovascular, repair
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 12 May 2020 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 inclusion / exclusion criteria.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular repairEndovascular repair of thoracoabdominal aneurysm using stent grafts. | Device | – |
Primary outcome
Mortality
Time frame: 30-day
Rate of all-cause mortality
37 secondary outcomes
Mortality
Time frame: 24 hours
Mortality
Time frame: 3-6, 12, 24, 36, 60 months
Rupture
Time frame: 30-day, 3-6, 12, 24, 36, 60 months
Major Adverse Events (MAE)
Time frame: prior to discharge, 30 days, 3-6, 12, 24, 36, 60 months
Number of intervention(s)
Time frame: perioperative
Delivery time
Time frame: perioperative
Reintervention
Time frame: 30 days, 3-6, 12, 24, 36, 60 months
Endoleak Type Ia
Time frame: 12, 24, 36, 60 months
Endoleak Type Ib
Time frame: 12, 24, 36, 60 months
Endoleak Type Ic
Time frame: 12, 24, 36, 60 months
Endoleak Type II
Time frame: 12, 24, 36, 60 months
Endoleak Type III
Time frame: 12, 24, 36, 60 months
Endoleak Type IV
Time frame: 12, 24, 36, 60 months
Endoleak of unknown origin
Time frame: 12, 24, 36, 60 months
Proximal intercomponent separation
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Distal intercomponent separation
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Integrity
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Kinking
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of 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
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Primary patency of 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
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Secondary patency
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
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
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
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
Time frame: prior to discharge/30 days, 12, 24, 36, 60 months
Infection
Time frame: 30-day, 12, 24, 36, 60 months
Primary technical success
Time frame: 24 hours
Technical success
Time frame: 24 hours
Primary clinical success
Time frame: 12, 24, 36, 60 months
Clinical success
Time frame: 12, 24, 36, 60 months
Stable aneurysm size
Time frame: 12, 24, 36, 60 months
Decreasing (< 5 mm) aneurysm size
Time frame: 12, 24, 36, 60 months
Increasing (> 5 mm) aneurysm size
Time frame: 12, 24, 36, 60 months
Stent graft removal
Time frame: 24 hours, prior to discharge/30 days, 12, 24, 36, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
Dittmar Böckler, Prof. Dr. study director
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Germany.
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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
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-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.