Last updated: February 6, 2024
Sponsor: JOTEC GmbH
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Heart Disease
Cardiovascular Disease
Treatment
endovascular repair
Clinical Study ID
NCT04383145
INNER-B
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 aortaranging from 40 mm proximal to the celiac trunk to 20 mm distal to the lowest renalartery
- 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 ≥ 20mm)
- Patient must be available for the appropriate follow-up times for the duration of thestudy
- Patient has signed the informed consent before implantation of the E-nside Stent Graft
Exclusion
Exclusion Criteria:
- Patient has allergies to materials necessary for endovascular repair (e.g. contrastmedia, 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 enrolment
- Patient has untreated hyperthyroidism
- Patient has a malignancy (progressive, stable or partial remission) with less thanone-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 courseof the study.
- Patient has a life expectancy of less than 3 years
Study Design
Total Participants: 150
Treatment Group(s): 1
Primary Treatment: endovascular repair
Phase:
Study Start date:
July 15, 2020
Estimated Completion Date:
February 28, 2030
Study Description
Connect with a study center
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
Hospital Clínico Universitario de Santiago
Santiago De Compostela, 15706
SpainSite Not Available
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