Evaluation of the GORE® Ascending Stent Graft
ARISEII
1 other identifier
interventional
370
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedStudy Start
First participant enrolled
November 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2034
April 28, 2026
September 1, 2025
5.8 years
March 23, 2023
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary effectiveness endpoint as measured by device technical success and absence of reintervention.
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
30 Days
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.
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
30 Days
Secondary Outcomes (2)
Secondary endpoints as measured as a composite of procedural and treatment success.
30 Days, and 6, 12, 24, 36, 48 and 60 months
Secondary endpoint as measured by Short Form-36® physical component summary (PCS)
12 months
Study Arms (3)
ASG device only in Ascending Aorta
EXPERIMENTALAscending Aortic Isolated Lesions, Pseudoaneurysms and Penetrating Aortic Ulcers in subjects at high-risk for surgical repair, treated with endovascular repair using the ASG device alone.
ASG + TBE
EXPERIMENTALAscending Aorta/Aortic Arch Isolated Lesions and Chronic De Novo Dissections in subjects at high-risk for surgical repair, treated with endovascular repair using the ASG and TBE devices.
Surgical Follow-up Cohort
OTHEROpen surgical repair of ascending aorta in subjects at high-risk for surgical repair
Interventions
Endovascular aortic repair of the ascending aorta
Open surgical repair of the ascending aorta and/or the aortic arch
Endovascular aortic repair of the ascending aorta/aortic arch
Eligibility Criteria
You may qualify if:
- The patient is/has:
- Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm
- Fusiform aneurysm (≥50mm or documented growth rate \>0.5cm/year)
- Saccular aneurysm (no diameter criteria)
- Pseudoaneurysms (\>30 days post-surgery, no diameter criteria) Non-aneurysm
- Penetrating Aortic Ulcers (PAUs) (no diameter criteria)
- Pseudoaneurysms, following open surgical repair of a Type A dissection (\>30 days post-surgery, no diameter criteria)
- Anatomic compatibility with ASG device based on Gore Imaging Sciences review.
- Treatment must be limited to the ascending aorta
- Lesion location is ≥2cm distal to the most distal coronary artery ostia
- Distal extent of the lesion is located ≥2cm proximal to the origin of the Brachiocephalic Artery (BCA)
- Proximal and distal landing zones must be ≥2cm in length
- Landing zones cannot be heavily calcified, or heavily thrombosed
- Landing zone diameter between 27mm - 48mm
- 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.
- +8 more criteria
You may not qualify if:
- The patient is/has:
- De novo Type A dissection
- Requires immediate treatment
- Dissected great vessels requiring treatment
- Anticipated need for coronary or aortic valve intervention within one year post treatment
- Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment
- Complex percutaneous coronary intervention (PCI) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment
- Open chest surgical repair within 30 days prior to treatment
- Presence of Intramural Hematoma (IMH) in landing zones
- Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device
- Aortic insufficiency grade 3 or greater
- Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair
- Concomitant vascular disease requiring treatment that is not planned for index endovascular procedure
- Any stroke or myocardial infarction within 6 weeks prior to treatment
- 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
- +79 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
MemorialCare Heart and Vascular Institute - Long Beach Medical Center
Long Beach, California, 90806, United States
Keck Medical Center University of Southern California, HCC II
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford Hospital
Stanford, California, 94305, United States
University of Colorado Hospital Authority
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida - Gainesville
Gainesville, Florida, 32610, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern University -Bluhm Cardiovascular Institute, Clinical Trials Unit
Chicago, Illinois, 60611, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Frankel Cardiovascular Center
Ann Arbor, Michigan, 48109, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine - St. Louis
St Louis, Missouri, 63110, United States
Hackensack UMC
Hackensack, New Jersey, 07601, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
OhioHealth Research and Innovation Institute
Columbus, Ohio, 43214, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19105, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756, United States
Methodist DeBakey Heart & Vascular Center
Houston, Texas, 77030, United States
The Heart Hospital at Baylor Plano
Plano, Texas, 75093, United States
Intermountain Heart Institute
Murray, Utah, 84107, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Sentara Mid Atlantic Cardiothoracic Surgeons
Norfolk, Virginia, 23507, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
West Virginia University Medicine
Morgantown, West Virginia, 26506, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Roselli, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 6, 2023
Study Start
November 28, 2023
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
January 1, 2034
Last Updated
April 28, 2026
Record last verified: 2025-09