CompletedNo phase
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
Key facts
- Who runs it
- JOTEC GmbH
- Where
- Australia, New Zealand, and Thailand8 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 16 people enrolled
- Started
- 1 Jan 2022
- Ended
- 8 Sept 2026
- Type of study
- Observational
- Record updated
- 29 October 2026
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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 a congenital degenerative collagen disease or connective tissue disorder
- Patient has a malignancy (progressive, stable or partial remission)
- Patient had a myocardial infarction or cerebrovascular accident < 3 months ago
- Patient has thrombocytopenia (platelet count < 150000/μl)
- Patient has an eGFR < 30 ml/min/1.73m2 before the intervention
- 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
- Diameter of ostium of branch vessel to be treated < 4 mm
- Patient has untreated hyperthyroidism
- 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
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 29 October 2026