Status:
RECRUITING
A Study in Patients With Thoracoabdominal Aortic Aneurysm Treated With the E-nside TAAA Multibranch Stent Graft System
Lead Sponsor:
JOTEC GmbH
Conditions:
Vascular Aneurysm
Eligibility:
All Genders
18-85 years
Brief Summary
The INNER-B post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a thoracoabdominal aneurysm when treated by the E-nside TAAA Multibranch Stent Graft Syste...
Detailed Description
In this study patients will be observed, who receive an E-nside TAAA Multibranch Stent Graft System for the endovascular treatment of a degenerative, atherosclerotic thoracoabdominal aortic aneurysm. ...
Eligibility Criteria
Inclusion
- 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
- 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 enrolment
- Patient has untreated hyperthyroidism
- Patient has a malignancy (progressive, stable or partial remission) with less than one-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 course of the study.
- Patient has a life expectancy of less than 3 years
Key Trial Info
Start Date :
July 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04383145
Start Date
July 15 2020
End Date
February 28 2030
Last Update
February 7 2024
Active Locations (1)
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1
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120