A Study in Patients With Thoracoabdominal Aortic Aneurysm Treated With the E-nside TAAA Multibranch Stent Graft System

Study Overview
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Brief Summary
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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 System. The secondary objective is to evaluate the safety and clinical performance of the device.

Detailed Description
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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. 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. The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.

Official Title
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INNER-B - A 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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Vascular Aneurysm

Intervention / Treatment
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* Device: endovascular repair


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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: endovascular repair|Endovascular repair of thoracoabdominal aneurysm using stent grafts.|

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-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of all-cause mortality in peri-operative periods (all related interventions) | 24 hours | 
| Mortality | Rate of all-cause mortality | 3-6, 12, 24, 36, 60 months | 
| Rupture | Rate of patients with aneurysm rupture | 30-day, 3-6, 12, 24, 36, 60 months | 
| Major Adverse Events (MAE) | Rate of patients with major adverse events (aneurysm related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, visceral ischemia (bowel ischemia with surgery or submission to ICU or bowel necrosis with surgery or submission to ICU), new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, new permanent paraplegia, new permanent paraparesis, lower limb ischemia (increase in Rutherford classification) (product-related, procedure-related, aneurysm-related) | prior to discharge, 30 days, 3-6, 12, 24, 36, 60 months | 
| Number of intervention(s) | Rate of interventions in peri-operative periods (all related interventions until index procedure) | perioperative | 
| Delivery time | 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 | perioperative | 
| Reintervention | Rate of reintervention(s) | 30 days, 3-6, 12, 24, 36, 60 months | 
| Endoleak Type Ia | Rate of patients with type Ia endoleak | 12, 24, 36, 60 months | 
| Endoleak Type Ib | Rate of patients with type Ib endoleak | 12, 24, 36, 60 months | 
| Endoleak Type Ic | Rate of patients with type Ic endoleak | 12, 24, 36, 60 months | 
| Endoleak Type II | Rate of patients with type II endoleak | 12, 24, 36, 60 months | 
| Endoleak Type III | Rate of patients with type III endoleak | 12, 24, 36, 60 months | 
| Endoleak Type IV | Rate of patients with type IV endoleak | 12, 24, 36, 60 months | 
| Endoleak of unknown origin | Rate of patients with endoleak of unknown origin | 12, 24, 36, 60 months | 
| Proximal intercomponent separation | Rate of patients with intercomponent separation at the proximal end of the E-nside stent graft > 10 mm | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Distal intercomponent separation | Rate of patients with intercomponent separation at the distal end of the E-nside stent graft > 10 mm | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Integrity | Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break) | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Kinking | Rate of patients with E-nside stent graft or bridging stent graft kinking | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Primary patency | Rate of primary patency of bridging stents | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Primary patency of bridging stent of the celiac trunk | Rate of primary patency of the bridging stent of the celiac trunk | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Primary patency of bridging stent of the superior mesenteric artery | Rate of primary patency of the bridging stent of the superior mesenteric artery | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Primary patency of bridging stent of the right renal artery | Rate of primary patency of the bridging stent of the right renal artery | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Primary patency of bridging stent of the left renal artery | Rate of primary patency of the bridging stent of the left renal artery | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Secondary patency | Rate of secondary patency of bridging stents | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Secondary patency of the bridging stent of the celiac trunk | Rate of secondary patency of the bridging stent of the celiac trunk | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Secondary patency of the bridging stent of the superior mesenteric artery | Rate of secondary patency of the bridging stent of the superior mesenteric artery | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Secondary patency of the bridging stent of the right renal artery | Rate of secondary patency of the bridging stent of the right renal artery | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Secondary patency of the bridging stent of the left renal artery | Rate of secondary patency of the bridging stent of the left renal artery | prior to discharge/30 days, 12, 24, 36, 60 months | 
| Infection | Rate of patients with stent graft infection | 30-day, 12, 24, 36, 60 months | 
| Primary technical success | Rate of patients with primary technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated within 24 h after the index procedure. Successful introduction and deployment of the E-nside TAAA Multibranch Stent Graft in the absence of: Surgical conversion Mortality Reintervention Unplanned branch vessel occlusion (post-operative occlusion) Including: Secure proximal and distal fixation Patent treated branch vessels | 24 hours | 
| Technical success | Rate of patients with technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure. | 24 hours | 
| Primary clinical success | Rate of patients with primary clinical success. Primary clinical success is reported on an intent-to-treat basis and is reached if the following criteria are fulfilled at the time of follow-up starting at 12 months follow-up: Successful deployment of the endovascular devices at the intended location in the absence of: Death as result of aneurysm-related treatment Conversion to open repair Reintervention after index procedure Occlusion of treated branch vessels Type I or III endoleak Increasing aneurysm size Aneurysm rupture | 12, 24, 36, 60 months | 
| Clinical success | Rate of patients with clinical success. Clinical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure. | 12, 24, 36, 60 months | 
| Stable aneurysm size | Rate of patients with stable aneurysm size | 12, 24, 36, 60 months | 
| Decreasing (< 5 mm) aneurysm size | Rate of patients with decreasing aneurysm size | 12, 24, 36, 60 months | 
| Increasing (> 5 mm) aneurysm size | Rate of patients with increasing aneurysm size | 12, 24, 36, 60 months | 
| Stent graft removal | Rate of patients with removal or failure to implant the E-nside TAAA Multibranch Stent Graft | 24 hours, prior to discharge/30 days, 12, 24, 36, 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoabdominal, aorta, aneurysm, endovascular, repair