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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