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

Active, not recruiting

Conditions: Aortic Dissection

Interventions: Device: GORE® Ascending Stent Graft

Registration Number: NCT02380716

Lead Sponsor: W.L.Gore & Associates

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

Detailed Description: 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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 21

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GORE® Ascending Stent Graft	GORE® Ascending Stent Graft	Treatment with the GORE® Ascending Stent Graft

Primary Outcome Measures

Name	Time	Method
All Cause Mortality at 30 Days Post-procedure	30 days post-procedure	Number of subjects that die of any cause within 30 days post-procedure

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months	30 days, 6 months, and 12 months post procedure	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
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months	30 days, 6 months, and 12 months post procedure	Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee
Successful Dissection Treatment (Technical Success)	At removal of device deployment system, up to conclusion of procedure	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.
Aorta-related Mortality	30 days post procedure	Assessed by reported adverse events and adjudicated by a Clinical Events Committee
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months	30 days, 6 months, and 12 months post procedure	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)\\*
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months	30 days, 6 months, and 12 months post procedure	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.