Evaluation of the GORE® Ascending Stent Graft
At a glance
Conditions
Where it's being run
41 sites across 27 statesStudy leadership
- Eric Roselli, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- Primary effectiveness endpoint as measured by device technical success and absence of reintervention.30 Days
The primary effectiveness endpoint is a composite of the following events through one month post procedure: Device Technical Success and Absence of Reintervention. Technical Success is defined as including: 1. Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, and; 2. Accurate placement of the device at the intended implantation site, and 3. Patency of the graft in absence of clinically significant device deformations (e.g., kinking, stent eversion, mal-deployment, misaligned deployment), and Absence of reintervention is defined as: The absence of unanticipated additional procedures related to the device, procedure, or withdrawal of the delivery system
- Primary Safety Endpoint as measured by a composite of the absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, and new onset renal failure requiring permanent dialysis.30 Days
The primary safety endpoint is a composite of the following events through 30 days post endovascular procedure: * Aortic rupture * Lesion-related mortality * Disabling Stroke * Permanent paraplegia * Permanent paraparesis * New onset renal failure requiring permanent dialysis