GORE® Ascending Stent Graft for Type A Aortic Dissections
This study is testing a device called the GORE® Ascending Stent Graft (ASG device) to treat a serious heart condition called de novo Type A aortic dissection. This is when the main artery leaving your heart (aorta) tears. The study aims to see how safe and effective the ASG device is for people who are considered high-risk for traditional open surgery. You might be able to join if you are 18 or older, have a new Type A aortic dissection that started within 30 days, and it can be treated with the ASG device. The study will look at how safe and effective the device is after 30 days. The current status of this study is unclear, and it plans to enroll 112 participants.
- Study design
- This is a single-arm study, meaning all participants will receive the GORE® Ascending Stent Graft. It is planned to include 112 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety and effectiveness of the device will be measured at 30 days after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
At a glance
Conditions
Where it's being run
22 sites across 17 statesStudy leadership
- Eric Roselli, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
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What this trial measures
- Primary Safety Endpoint30 Days
Composite of the following events: Death ≤30 days of the index endovascular procedure, or during initial hospitalization, whichever is later Disabling Stroke ≤30 days following the index endovascular procedure
- Primary Effectiveness Endpoint30 Days
Clinical Success, a composite of: Assisted Technical Success (at end of index endovascular procedure) Absence of the following (cumulative through 30-days, except as specified): Aortic rupture Death ≤30days of the index endovascular procedure, or during initial hospitalization, whichever is later Study Device Reintervention Conversion to open surgical repair