A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study, patients will be observed who are planned to be treated an E-nside TAAA Multibranch Stent Graft System for endovascular repair of a degenerative, atherosclerotic thoracoabdominal aortic aneurysm. The E-nside TAAA Multibranch Stent Graft will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-nside TAAA Multibranch Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. Patient data will be documented in an eCRF at the following time points: Pre-operative planning, intervention(s), discharge(s) from hospital, 30 days, 3-6 and 12 months follow-up. The period of data collection will be approximately 12 months (depending on the time point of the 12 months FU visit) from the index procedure for each patient. A 100% source data verification will be performed regarding patient information and consent, criteria of patients to be documented, pre-operative planning, intervention(s), treatment results, adverse events, death, and reintervention. Complete DICOM image files of the CT scans will be sent to a CoreLab for independent second evaluation.

Official Title
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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

Conditions
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Thoracoabdominal Aortic Aneurysm

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of all-cause mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of all-cause mortality | 3-6 months, 12 months | 
| Rupture | Rate of patients with aneurysm rupture | through study completion, an average of 12 months | 
| Major adverse events | Rate of patients with major adverse events | Prior to Discharge, 30 days, 3-6 months, 12 months | 
| Number of interventions | Rate of interventions in peri-operative periods | Intra-Op | 
| 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 | 
| Reinterventions | Rate of reinterventions | 30 days, 3-6, 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Stent graft infection | Rate of patients with stent graft infection | through study completion, an average of 12 months | 
| Primary and secondary technical success | Rate of patients with primary/secondary technical success | 24 hours | 
| Primary and secondary clinical success | Rate of patients with primary/secondary clinical success | 12 months | 
| Stable, decreasing or increasing aneurysm size | Rate of patients with stable, decreasing or increasing aneurysm size | 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysm, thoracoabdominal, aortic, vascular, surgery