N/A
N=21
ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
Aortic Dissection
Bottom Line
View on ClinicalTrials.gov: NCT02380716 ↗Enrolled (actual)
21
Serious AEs
90.5%
Results posted
Feb 2023
Primary outcome: Primary: All Cause Mortality at 30 Days Post-procedure — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GORE® Ascending Stent Graft (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause Mortality at 30 Days Post-procedure |
3 | — |
| SECONDARY Successful Dissection Treatment (Technical Success) |
17 | — |
| SECONDARY Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months |
9 | — |
| SECONDARY Individual MACCE Components Through 30 Days, 6 Months, and 12 Months |
3; 4; 4; 0; 0; 0 | — |
| SECONDARY Aorta-related Mortality |
3 | — |
| SECONDARY Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months |
0; 0; 0 | — |
| SECONDARY Endoleak Assessed Through 1 Month, 6 Months, and 12 Months |
3; 4; 4; 3; 3; 3 | — |
Summary
Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02380716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.