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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2021 |
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Main ID: |
NCT03187522 |
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Date of registration:
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11/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft
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Scientific title:
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An EU Post-Approval Registry of the TREO® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms |
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Date of first enrolment:
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June 22, 2017 |
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Target sample size:
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174 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03187522 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Germany
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Italy
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Netherlands
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Giovanni Torsello, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center of Vascular and Endovascular Surgery, Munster University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18 years
- Signed informed consent
- Willingness to comply with study follow-up
- Indication for elective endovascular repair
- Planned implantation of single Treo device system or aorto uni-iliac (AUI) device to
include any auxiliary device components
Exclusion Criteria:
- Intolerance to contrast media
- Emergency procedure
- Chimneys or fenestrated device procedures
- Connective tissue disease (e.g., Marfan's syndrome)
- High probability of non-adherence to follow-up requirements
- Current participation in a concurrent trial that may confound study results
- Female of childbearing potential in whom pregnancy cannot be excluded
- Previous endovascular or surgical AAA repair
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aortic Aneurysm, Abdominal
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Intervention(s)
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Device: TREO Stent-Graft System
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Primary Outcome(s)
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Aneurysm-related mortality
[Time Frame: 30 days post-procedure]
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Renal failure
[Time Frame: 30 days post-procedure]
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Paraplegia
[Time Frame: 30 days post-procedure]
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Stroke (excluding transient ischemic attack)
[Time Frame: 30 days post-procedure]
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Bowel ischemia
[Time Frame: 30 days post-procedure]
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Respiratory failure
[Time Frame: 30 days post-procedure]
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Treated aneurysm rupture
[Time Frame: 30 days post-procedure]
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Myocardial infarction
[Time Frame: 30 days post-procedure]
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Secondary Outcome(s)
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Limb Ischemia
[Time Frame: 30 days post-procedure]
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Major Adverse Events (MAE) at the follow-up time points
[Time Frame: 30 days post-procedure]
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Patient-reported quality of life (QOL)
[Time Frame: One year follow-up]
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Vascular access complications
[Time Frame: Vascular access will be evaluated on day of index procedure (implant)]
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Secondary procedures
[Time Frame: 5 years]
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Secondary ID(s)
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IP-0020-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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