A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
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A vizsgálat adatai
- Ki végzi
- JOTEC GmbH
- Azonosító
- NCT05954793
- A regiszteradat frissítve
- 2026. október 29.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.