An observational study in Thoracic Aortic Aneurysm, Thoracic Aortic Dissection and Stent-Graft Endoleak, sponsored by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery · Observational
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.
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.
131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.
This study's planned enrollment of 100 is below the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.
Browse Aortic Aneurysm, Thoracic studies →Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with aortic arch pathologies (aneurysm, pseudoanerysm, 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.
Mortality
Rate of all-cause mortality
Time frame: 30 days
Mortality
Rate of all-cause mortality in peri-operative periods (all related interventions)
Time frame: 24 hours
Mortality
Rate of all-cause mortality
Time frame: 3-6, 12, 24, 36, 48, 60 months
Rupture
Rate of patients with aneurysm rupture
Time frame: 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)
Time frame: 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)
Time frame: Perioperative
Delivery time
Rate of time intervals the branched-stent graft implantation
Time frame: Perioperative
Reintervention
Rate of reinterventions
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Endoleak
Rate of patients with endoleak
Time frame: 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
Time frame: 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)
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Kinking
Rate of patients with stent graft or bridging stent graft kinking
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Primary patency
Rate of primary patency of bridging stents
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary patency
Rate of secondary patency of bridging stents
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Infection
Rate of patients with stent graft infection
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Stable aneurysm size
Rate of patients with stable aneurysm size
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Decreasing
Rate of patients with decreasing (\<5mm) aneurysm size
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Increasing
Rate of patients with increasing (\>5mm) aneurysm size
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Plan to share: No — Data analyzed by core lab
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Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery