Clinical trial NCT02380716: ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
Official title: ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Dissection
Keywords: type A dissection
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
3. High surgical risk, as determined by the implanting physician
4. Adequate vascular access via transfemoral or retroperitoneal approach
5. An Informed Consent Form signed by Subject or legally authorized representative
6. Able to comply with protocol requirements including follow-up

Exclusion Criteria:

1. Planned aortic valve repair or replacement or coronary artery intervention within 30 days
2. Presence of mechanical heart valve in the aortic position
3. Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta
4. Aortic insufficiency grade 3+ or 4+
5. Known irreversible neurological injury
6. Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
7. Participation in another drug or medical device study within 1 year of study enrollment
8. Known history of drug abuse
9. Pregnant female at time of informed consent signature
10. Body habitus or other medical condition which prevents adequate visualization of the aorta
11. Systemic infection that could increase the risk of endovascular graft infection
12. Previous thoracic aortic surgery
13. Life expectancy \<12 months due to associated non-cardiac co-morbid conditions
14. Subject has known sensitivities or allergies to the device materials
15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
16. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Primary outcomes:
measure: All Cause Mortality at 30 Days Post-procedure
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Successful Dissection Treatment (Technical Success)
timeFrame: At removal of device deployment system, up to conclusion of procedure
measure: Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months
timeFrame: 30 days, 6 months, and 12 months post procedure
measure: Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
timeFrame: 30 days, 6 months, and 12 months post procedure
measure: Aorta-related Mortality
timeFrame: 30 days post procedure
measure: Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
timeFrame: 30 days, 6 months, and 12 months post procedure
measure: Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
timeFrame: 30 days, 6 months, and 12 months post procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California- Keck Medicine
state: California
Study officials:
References: