ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection

Study Overview
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Brief Summary
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Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

Detailed Description
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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.

Official Title
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ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection

Conditions
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Aortic Dissection

Intervention / Treatment
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* Device: GORE® Ascending Stent Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including: Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia Ascending aorta compatible with the GORE® Ascending Stent Graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure High surgical risk, as determined by the implanting physician Adequate vascular access via transfemoral or retroperitoneal approach An Informed Consent Form signed by Subject or legally authorized representative Able to comply with protocol requirements including follow-up Exclusion Criteria: Planned aortic valve repair or replacement or coronary artery intervention within 30 days Presence of mechanical heart valve in the aortic position Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta Aortic insufficiency grade 3+ or 4+ Known irreversible neurological injury Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome Participation in another drug or medical device study within 1 year of study enrollment Known history of drug abuse Pregnant female at time of informed consent signature Body habitus or other medical condition which prevents adequate visualization of the aorta Systemic infection that could increase the risk of endovascular graft infection Previous thoracic aortic surgery Life expectancy <12 months due to associated non-cardiac co-morbid conditions Subject has known sensitivities or allergies to the device materials Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE® Ascending Stent Graft<br>Treatment with the GORE® Ascending Stent Graft | Device: GORE® Ascending Stent Graft<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality at 30 Days Post-procedure | Number of subjects that die of any cause within 30 days post-procedure | 30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 30 days, 6 months, and 12 months post procedure | 
| Aorta-related Mortality | Assessed by reported adverse events and adjudicated by a Clinical Events Committee | 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 | 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)** | 30 days, 6 months, and 12 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type A dissection