Aorta; Lesion, Aortic Aneurysm, Thoracic, Aortic Dissection, Pseudoaneurysm
Conditions
Keywords
Ascending Aorta, Pseudoaneurysm, Aortic Lesion, Endovascular Repair, Aortic Aneurysm, Thoracic
Brief summary
The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.
Interventions
Endovascular aortic repair of the ascending aorta
DEVICEGORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)
Endovascular aortic repair of the ascending aorta/aortic arch
PROCEDURESurgery
Open surgical repair of the ascending aorta and/or the aortic arch
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ASG Device Alone Arm The patient is/has: 1. Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm 1. Fusiform aneurysm (≥50mm or documented growth rate \>0.5cm/year) 2. Saccular aneurysm (no diameter criteria) 3. Pseudoaneurysms (\>30 days post-surgery, no diameter criteria) Non-aneurysm 4. Penetrating Aortic Ulcers (PAUs) (no diameter criteria) 5. Pseudoaneurysms, following open surgical repair of a Type A dissection (\>30 days post-surgery, no diameter criteria) 2. Anatomic compatibility with ASG device based on Gore Imaging Sciences review. 1. Treatment must be limited to the ascending aorta 2. Lesion location is ≥2cm distal to the most distal coronary artery ostia 3. Distal extent of the lesion is located ≥2cm proximal to the origin of the Brachiocephalic Artery (BCA) 4. Proximal and distal landing zones must be ≥2cm in length 5. Landing zones cannot be heavily calcified, or heavily thrombosed 6. Landing zone diameter between 27mm - 48mm 7. For patients with prior replacement of the ascending aorta and/or aortic arch by an endovascular or surgical graft, there must be at least ≥2 cm overlap of ASG device and previously implanted graft. 3. Considered high-risk for open surgical repair by meeting any of the following criteria: 1. ≥75 years of age 2. Previous median sternotomy 3. Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and/or aortic arch surgeon (e.g., cardiothoracic surgeon). 4. Age ≥18 years at time of informed consent signature 5. Adequate vascular access via transfemoral or retroperitoneal approach 6. Informed Consent Form (ICF) signed by the subject or legally authorized representative 7. Agrees to comply with protocol requirements, including imaging and 5-year follow-up
Exclusion criteria
ASG Device Alone Arm The patient is/has: 1. De novo Type A dissection 2. Requires immediate treatment 3. Dissected great vessels requiring treatment 4. Anticipated need for coronary or aortic valve intervention within one year post treatment 5. Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment 6. Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment 7. Open chest surgical repair within 30 days prior to treatment 8. Presence of Intramural Hematoma (IMH) in landing zones 9. Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device 10. Aortic insufficiency grade 3 or greater 11. Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair 12. Concomitant vascular disease requiring treatment that is not planned for index endovascular procedure 13. Any stroke or myocardial infarction within 6 weeks prior to treatment 14. Presence of protruding and/or irregular thrombus and/or atheroma in the ascending aorta or aortic arch or any other factors that could increase the risk of stroke based on imaging review 15. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome, EDS) 16. Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor 17. Known history of drug abuse within one year of treatment 18. Pregnant at time of procedure 19. Active infected aorta, mycotic aneurysm 20. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) 21. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) \<30 (mL/min/1.73 m2) or currently requiring dialysis 22. Life expectancy \<12 months 23. Known sensitivities or allergies to the device materials 24. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment 25. Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta Inclusion Criteria: ASG + TBE Device Arm The patient is/has: 1. Ascending and/or Arch Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device and meeting any of the following criteria: Aneurysms 1. Fusiform aneurysm (≥55 mm or documented growth rate \>0.5cm/year) 2. Saccular aneurysm (no diameter criteria) 3. Pseudoaneurysms (\>30 days post-surgery, no diameter criteria) Non-aneurysms 4. Penetrating Aortic Ulcers (no diameter criteria) 5. Pseudoaneurysms, following open surgical repair of a Type A dissection (\>30 days post-surgery, no diameter criteria) 6. Chronic de novo (\>90 days) Type A aortic dissection requiring treatment * Chronic de novo aortic dissection with primary entry tear in the ascending aorta or arch * Chronic de novo aortic dissection with primary entry tear in the descending thoracic aorta with retrograde involvement of the aortic arch and/or ascending aorta 7. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (\>30 days post-surgery) 2. Anatomic compatibility with ASG device used in combination with the TBE Device based on Gore Imaging Sciences review. Proximal Aortic Landing Zone: 1. Landing zone is native aorta or surgical graft 2. Lesion location is ≥2cm distal to the most distal coronary artery ostia 3. Proximal landing zone must be ≥2cm in the ascending aorta. 4. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed 5. Landing zone diameter between 27mm - 48mm 6. Acceptable proximal landing zone outer curvature length for the required device Branch Vessel Landing Zone: 1. Length of ≥2.5 cm proximal to first major branch vessel 2. Target branch vessel inner diameters of 11-18 mm 3. Target branch vessel landing zone must be in native vessel that cannot be heavily calcified, or heavily thrombosed Distal Aortic Landing Zone: 1. Outer curvature must be ≥2 cm proximal to the celiac artery 2. Aortic inner diameters between 16-42 mm 3. Landing zone in native aorta or previously implanted GORE® TAG® Conformable Thoracic Stent Graft (CTAG Device) 3. Considered high-risk for open surgical repair by meeting any of the following criteria: 1. ≥75 years of age 2. Previous median sternotomy 3. Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and/or aortic arch surgeon (e.g., cardiothoracic surgeon). 4. Age ≥18 years at time of informed consent signature 5. Adequate vascular access via transfemoral or retroperitoneal approach 6. Informed Consent Form (ICF) signed by the subject or legally authorized representative 7. Agrees to comply with protocol requirements, including imaging and 5-year follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary effectiveness endpoint as measured by device technical success and absence of reintervention. | 30 Days | The primary effectiveness endpoint is a composite of the following events through one month post procedure: Device Technical Success and Absence of Reintervention. Technical Success is defined as including: 1. Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, and; 2. Accurate placement of the device at the intended implantation site, and 3. Patency of the graft in absence of clinically significant device deformations (e.g., kinking, stent eversion, mal-deployment, misaligned deployment), and Absence of reintervention is defined as: The absence of unanticipated additional procedures related to the device, procedure, or withdrawal of the delivery system |
| Primary Safety Endpoint as measured by a composite of the absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, and new onset renal failure requiring permanent dialysis. | 30 Days | The primary safety endpoint is a composite of the following events through 30 days post endovascular procedure: * Aortic rupture * Lesion-related mortality * Disabling Stroke * Permanent paraplegia * Permanent paraparesis * New onset renal failure requiring permanent dialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoints as measured as a composite of procedural and treatment success. | 30 Days, and 6, 12, 24, 36, 48 and 60 months | Two secondary endpoints are planned for the study with no inferential analysis. Composite endpoint of procedural success elements measured at one month follow-up Composite endpoint of treatment success elements measured at all appropriate follow-up windows |
| Secondary endpoint as measured by Short Form-36® physical component summary (PCS) | 12 months | Short Form-36® PCS measured at the one year follow-up visit with inferential analysis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Roselli, MD
The Cleveland Clinic
Outcome results
None listed