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Not yet recruiting NCT07480395

Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.

— Observational Complex Aortic Aneurysms Thoracoabdominal Aneurysm Fenestrated Endovascular Aortic Repair Endovascular Aortic Repair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Complex Aortic Aneurysms, Thoracoabdominal Aneurysm, Fenestrated Endovascular Aortic Repair, Endovascular Aortic Repair. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.

Overview

The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion

Detailed description

Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set

Primary outcome measures

  • Freedom from Target Vessel Instability [Time frame: through 1 year Follow-up]
Secondary outcome measures (12)
  • Target Vessel Technical Success [Time frame: At procedure]
  • Procedural Technical Success [Time frame: at procedure]
  • Clinical Success [Time frame: through 5-year follow-up]
  • Major Adverse Events [Time frame: through 5-year follow-up]
  • Freedom from Aneurysm-Related Mortality [Time frame: through 5-year follow-up]
  • Freedom from Target Vessel Instability through 5-year follow-up [Time frame: through 5-year follow-up]
  • Primary Patency [Time frame: through 5-year follow-up]
  • Freedom from Reintervention [Time frame: through 5-year follow-up]
  • Survival [Time frame: through 5-year follow-up]
  • Aneurysm sac changes [Time frame: through 5-year follow-up]
  • Primary Assisted Patency [Time frame: through 5-year follow-up]
  • Secondary Patency [Time frame: through 5-year follow-up]

Eligibility criteria

Inclusion criteria

  • Informed Consent Form (ICF) is signed by Subject.
  • Age ≥ 18 years at time of informed consent signature.
  • Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
  • Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).
  • Patient is willing to adhere to the institutional standard of care follow-up.

Exclusion criteria

  • Patient has a prior visceral artery stenting not associated with registry procedure.
  • Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
  • Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.
  • Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
  • Patient has known coagulation disorders including hypercoagulability that are not amenable to treatment.
  • Patient has a life expectancy < 1-year.
  • Patient is participating in an investigational study which may confound registry results, unless approved by Gore

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07480395 · VSC 25-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗