A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)

Launched by JOTEC GMBH · Jul 13, 2023

Keywords

ClinConnect Summary

The INNER-B-APAC clinical trial is studying a new treatment option for patients with a condition known as thoracoabdominal aortic aneurysms, which are bulges in a major blood vessel that can be dangerous if they rupture. The trial focuses on a specific device called the E-nside TAAA Multibranch Stent Graft System, which is designed to help repair these aneurysms safely through a less invasive procedure. Researchers want to ensure that this device is safe and performs well in real-world situations after it has been approved for use.

To be eligible for this study, participants need to be between 18 and 85 years old and have a specific type of aneurysm that fits certain criteria. They should also have suitable blood vessels for the procedure and be able to attend follow-up appointments. It’s important to note that people with certain medical conditions, such as allergies to materials used in the treatment or recent heart issues, may not be able to participate. Participants in the trial can expect close monitoring and follow-ups to assess their health and the effectiveness of the treatment. This study is currently recruiting, so it offers a potential new option for those who qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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 intervention
• • Patient has untreated hyperthyroidism
• • Patient has a malignancy (progressive, stable or partial remission)
• • 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