ENDOBARC-S Study: Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain

Study Overview
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Brief Summary
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The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. The secondary objective is to evaluate the safety and clinical performance of the studied devices.

Detailed Description
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In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices 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 branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). 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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ENDOBARC-S Study: Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain

Conditions
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Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis, Intramural Hematoma, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases

Intervention / Treatment
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* Device: Endovascular exclusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is between 18 and 90 years old Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0. Patient must be available for the appropriate follow-up times for the duration of the study Informed consent signed. Exclusion Criteria: Patient less than 18 years old or more than 90 years old. 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 thrombocytopenia (platelet count < 150000/µl) Patient has untreated hyperthyroidism Patient has a progressive or untreated malignancy. Patient is pregnant or breastfeeding. Patient has a life expectancy of less than 1 year. Not informed consent signed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with aortic arch pathologies treated by branch stent graft systems<br>Patients with aortic arch pathologies treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. | Device: Endovascular exclusion<br>* Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.<br>|

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 in peri-operative periods (all related interventions) | 24 hours | 
| Mortality | Rate of all-cause mortality | 3-6, 12, 24, 36, 48, 60 months | 
| Rupture | Rate of patients with aneurysm rupture | 3-6, 12, 24, 36, 48, 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, 48, 60 months | 
| Number of interventions | Rate of interventions in peri-operative periods (all related interventions until index procedure) | Perioperative | 
| Delivery time | Rate of time intervals the branched-stent graft implantation | Perioperative | 
| Reintervention | Rate of reinterventions | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Endoleak | Rate of patients with endoleak | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Proximal intercomponent separation | Rate of patients with intercomponent separation at the proximal end of the Nexus stent-graft system > 10 mm | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Integrity | Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break) | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Kinking | Rate of patients with stent graft or bridging stent graft kinking | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Primary patency | Rate of primary patency of bridging stents | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Secondary patency | Rate of secondary patency of bridging stents | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Infection | Rate of patients with stent graft infection | 30 days, 3-6, 12, 24, 36, 48, 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 multibranch stent-graft systems 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 | 30 days, 3-6, 12, 24, 36, 48, 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. | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Stable aneurysm size | Rate of patients with stable aneurysm size | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Decreasing | Rate of patients with decreasing (<5mm) aneurysm size | 30 days, 3-6, 12, 24, 36, 48, 60 months | 
| Increasing | Rate of patients with increasing (>5mm) aneurysm size | 30 days, 3-6, 12, 24, 36, 48, 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aorta, Thoracic aortic aneurysm, Thoracic aorta dissection, Endovascular repair