Thoracoabdominal Aortic Aneurysm Clinical Trial
Official title:
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
NCT number | NCT05954793 |
Other study ID # | INNER-B-APAC |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | January 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Alfred Health | Melbourne | |
Australia | Sir Charles Gairdner Hospital | Perth | |
Australia | Royal North Shore Hospital | Saint Leonards | |
Australia | Gold Coast University Hospital | Southport | |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Waikato Hospital Hamilton | Hamilton | |
Thailand | Siriraj Hospital | Bangkok | |
Thailand | Prince of Songkla University - Songklanagarind Hospital | Songkhla |
Lead Sponsor | Collaborator |
---|---|
JOTEC GmbH |
Australia, New Zealand, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Rate of all-cause mortality | 30 days | |
Secondary | Mortality | Rate of all-cause mortality | 3-6 months, 12 months | |
Secondary | Rupture | Rate of patients with aneurysm rupture | through study completion, an average of 12 months | |
Secondary | Major adverse events | Rate of patients with major adverse events | Prior to Discharge, 30 days, 3-6 months, 12 months | |
Secondary | Number of interventions | Rate of interventions in peri-operative periods | Intra-Op | |
Secondary | Time E-nside delivery system remained in access vessels | Rate of time intervals the E-nside delivery system remained in the access vessels in relation to the number of branches treated with pre-cannulation | through study completion, an average of 12 months | |
Secondary | Reinterventions | Rate of reinterventions | 30 days, 3-6, 12 months | |
Secondary | Type Ia, Ib, Ic, II, III, IV endoleaks and endoleaks of unknown origin | Rate of patients with type Ia, Ib, Ic endoleak (at 12 months follow-up) | 12 months | |
Secondary | Intercomponent separation | Rate of patients with intercomponent separation at the proximal or distal end of the E-nside stent graft > 10 mm | Prior to Discharge, 30 days, 3-6 months, 12 months | |
Secondary | Loss of device integrity | Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break) | Prior to Discharge, 30 days, 3-6 months, 12 months | |
Secondary | Kinking of E-nside Stent Graft or bridging stents | Rate of patients with E-nside stent graft or bridging stent kinking | Prior to Discharge, 30 days, 3-6 months, 12 months | |
Secondary | Primary and secondary patency (overall and separately for each type of branch) | Rate of primary/secondary patency of bridging stents Rate of primary/secondary patency of the bridging stent of the celiac trunk Rate of primary/secondary patency of the bridging stent of the superior mesenteric artery Rate of primary/secondary patency of the bridging stent of the right renal artery Rate of primary/secondary patency of the bridging stent of the left renal artery Rate of primary/secondary patency of branch vessels treated | Prior to Discharge, 30 days, 3-6 months, 12 months | |
Secondary | Stent graft infection | Rate of patients with stent graft infection | through study completion, an average of 12 months | |
Secondary | Primary and secondary technical success | Rate of patients with primary/secondary technical success | 24 hours | |
Secondary | Primary and secondary clinical success | Rate of patients with primary/secondary clinical success | 12 months | |
Secondary | Stable, decreasing or increasing aneurysm size | Rate of patients with stable, decreasing or increasing aneurysm size | 12 months | |
Secondary | Removal or failure to implant the stent graft | Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft | through study completion, an average of 12 months |
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