An observational study in Aortic Aneurysm, Abdominal and Aorto Iliac Aneurysm, sponsored by Medtronic Cardiovascular. Terminated at 9 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Medtronic Cardiovascular · Observational
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.
959 studies on the registry are indexed under Aneurysm; 174 are open to participants now.
This study's enrollment of 108 is below the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Medtronic Cardiovascular is the lead sponsor of 66 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair.
Patient's AAA meets at least one of the following criteria:
Exclusion Criteria:
All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment if treated with the Fortevo Endograft.
Device: Fortevo Endograft
The Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair.
Technical Success
The first primary endpoint is primary technical success. It consists of the following items: * Successful arterial access * Successful deployment of the Fortevo Endograft with secure proximal and distal fixation * Absence of type I or III endoleaks * Patent Fortevo Endograft without significant twist, kinking, or obstruction
Time frame: Within 24 hours of the Index procedure
Major Adverse Events (MAE)
The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. MAE are defined as any one of the following events: * Death * Myocardial Infarction * Stroke (excludes TIA) * Renal failure (excludes renal insufficiency) * Respiratory Failure (excludes COPD or pulmonary complications) * Paralysis (excludes paraparesis)
Time frame: Within 1-Month of Implantation
Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of: * Death as a result of aneurysm-related treatment * Type I or III endoleak * Fortevo Endograft infection * Fortevo Endograft thrombosis * Fortevo Endograft dilatation by 20% or more in diameter * Fortevo Endograft migration by 10mm or more at the proximal neck at 6-M and 12-M * Loss of Fortevo Endograft or Heli-FX EndoAnchor System integrity * Aneurysm expansion by 5mm (or more) in maximal diameter at 6-M and 12-M * Aneurysm rupture * Conversion to open repair
Time frame: 1-Month, 6-Months and 12-Months
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiovascular