Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft
This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
University of Southern California- Keck Medicine
Los Angeles, California, United States
All Cause Mortality at 30 Days Post-procedure
Number of subjects that die of any cause within 30 days post-procedure
Time frame: 30 days post-procedure
Successful Dissection Treatment (Technical Success)
Number of subjects with technical success defined as successful access to the aorta, successful deployment of the study device components, successful retrieval of the device delivery system, exclusion of the primary entry tear of the aortic dissection, and patency of the side branch device component, if used.
Time frame: At removal of device deployment system, up to conclusion of procedure
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months
Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee
Time frame: 30 days, 6 months, and 12 months post procedure
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Individual Components include: All Cause Mortality, Myocardial Infarction (MI), and Severe Stroke. Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee.
Time frame: 30 days, 6 months, and 12 months post procedure
Aorta-related Mortality
Assessed by reported adverse events and adjudicated by a Clinical Events Committee
Time frame: 30 days post procedure
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
Assessed on CT scans within the defined visits windows 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure
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Time frame: 30 days, 6 months, and 12 months post procedure
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Assessed on CT scans within the defined visits windows: 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure Definitions: Endoleak Type I (A and B): Endoleak arising at or from the prosthesis attachment site perfusing the treated region of the aorta. Endoleak Type IA: Endoleak at proximal aortic prosthesis attachment site. Endoleak Type IB: Endoleak at distal prosthesis attachment site. Endoleak Type II: Endoleak arising from a patent branch vessel of the excluded aorta perfusing the treated aorta, e.g., lumbar or inferior mesenteric branch. Endoleak Type III: Endoleak arising from the component junction(s) of the prosthesis or due to a defect in the graft material perfusing the treated region of the aorta. Endoleak Type IV: Endoleak arising through the graft fabric perfusing the treated region of the aorta. \*\*\*Endoleak categorizations have no directionality (i.e., cannot be considered better or worse)\*\*
Time frame: 30 days, 6 months, and 12 months post procedure