Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT05954793
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05954793
Study Brief:
Protocol Section:
NCT05954793