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Aortic Aneurysm, ThoracicARISEIINCT05800743

Evaluation of the GORE® Ascending Stent Graft

A study testing GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device) and Surgery in people with Aortic Aneurysm, Thoracic and Pseudoaneurysm, run by W.L.Gore & Associates at 41 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device) and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
41 sitesUnited States
Study dates
28 Nov 2023to Jan 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 64Show fewer
  • 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.
  • Considered high-risk for open surgical repair by meeting any of the following criteria:
  • ≥75 years of age
  • Previous median sternotomy
  • 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).
  • Age ≥18 years at time of informed consent signature
  • Adequate vascular access via transfemoral or retroperitoneal approach
  • Informed Consent Form (ICF) signed by the subject or legally authorized representative
  • Agrees to comply with protocol requirements, including imaging and 5-year follow-up
  • The patient is/has:
  • 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
  • Fusiform aneurysm (≥55 mm or documented growth rate >0.5cm/year)
  • Saccular aneurysm (no diameter criteria)
  • Pseudoaneurysms (>30 days post-surgery, no diameter criteria) Non-aneurysms
  • Penetrating Aortic Ulcers (no diameter criteria)
  • Pseudoaneurysms, following open surgical repair of a Type A dissection (>30 days post-surgery, no diameter criteria)
  • 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
  • Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (>30 days post-surgery)
  • Anatomic compatibility with ASG device used in combination with the TBE Device based on Gore Imaging Sciences review.
  • Proximal Aortic Landing Zone:
  • Landing zone is native aorta or surgical graft
  • Lesion location is ≥2cm distal to the most distal coronary artery ostia
  • Proximal landing zone must be ≥2cm in the ascending aorta.
  • Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
  • Landing zone diameter between 27mm - 48mm
  • Acceptable proximal landing zone outer curvature length for the required device
  • Branch Vessel Landing Zone:
  • Length of ≥2.5 cm proximal to first major branch vessel
  • Target branch vessel inner diameters of 11-18 mm
  • Target branch vessel landing zone must be in native vessel that cannot be heavily calcified, or heavily thrombosed
  • Distal Aortic Landing Zone:
  • Outer curvature must be ≥2 cm proximal to the celiac artery
  • Aortic inner diameters between 16-42 mm
  • Landing zone in native aorta or previously implanted GORE® TAG® Conformable Thoracic Stent Graft (CTAG Device)
  • Considered high-risk for open surgical repair by meeting any of the following criteria:
  • ≥75 years of age
  • Previous median sternotomy
  • 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).
  • Age ≥18 years at time of informed consent signature
  • Adequate vascular access via transfemoral or retroperitoneal approach
  • Informed Consent Form (ICF) signed by the subject or legally authorized representative
  • Agrees to comply with protocol requirements, including imaging and 5-year follow-up
  • Subjects who meet the following criteria will be followed:
  • The aortic lesion involves the ascending aorta and/or aortic arch
  • The subject is determined to be high-risk for open surgical repair per the protocol requirements
  • The subject is at least 18 years of age
  • The subject is willing to comply with the protocol requirements
  • Open surgery to repair the aortic lesion the patient was screened for is intended to be performed at the investigational site responsible for initiating the screening process for the study

Who cannot join

  • 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
Show all 53Show fewer
  • 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
  • Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome, EDS)
  • Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor
  • Known history of drug abuse within one year of treatment
  • Pregnant at time of procedure
  • Active infected aorta, mycotic aneurysm
  • Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication)
  • Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (mL/min/1.73 m2) or currently requiring dialysis
  • Life expectancy <12 months
  • Known sensitivities or allergies to the device materials
  • Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
  • Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
  • The patient is/has:
  • Acute and subacute de novo Type A dissection (defined as <90 days)
  • 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
  • Known degenerative connective tissue disease (e.g., Marfan Syndrome or Ehlers-Danlos Syndrome, EDS)
  • Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor
  • Known history of drug abuse within one year of treatment
  • Pregnant at time of procedure
  • Active infected aorta, mycotic aneurysm
  • Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication)
  • Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (mL/min/1.73 m2) or currently requiring dialysis
  • Life expectancy <12 months
  • Known sensitivities or allergies to the device materials
  • Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
  • Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
  • Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and/or state

Trial locations and contacts

41 sites in 1 country. Contact the study team or a site near you to ask about taking part.

41 sites in 1 country

United States41 sites

  • University of Michigan Frankel Cardiovascular Center

    Ann Arbor, Michigan, 48109

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Colorado Hospital Authority

    Aurora, Colorado, 80045

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Atrium Health

    Charlotte, North Carolina, 28204

  • Northwestern University -Bluhm Cardiovascular Institute, Clinical Trials Unit

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • OhioHealth Research and Innovation Institute

    Columbus, Ohio, 43214

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • University of Florida - Gainesville

    Gainesville, Florida, 32610

  • Corewell Health

    Grand Rapids, Michigan, 49503

  • Hackensack UMC

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Methodist DeBakey Heart & Vascular Center

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • MemorialCare Heart and Vascular Institute - Long Beach Medical Center

    Long Beach, California, 90806

  • Keck Medical Center University of Southern California, HCC II

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53792

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • West Virginia University Medicine

    Morgantown, West Virginia, 26506

  • Intermountain Heart Institute

    Murray, Utah, 84107

  • Sentara Mid Atlantic Cardiothoracic Surgeons

    Norfolk, Virginia, 23507

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19105

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • The Heart Hospital at Baylor Plano

    Plano, Texas, 75093

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University School of Medicine - St. Louis

    St Louis, Missouri, 63110

  • Stanford Hospital

    Stanford, California, 94305

  • University of South Florida

    Tampa, Florida, 33606

  • Westchester Medical Center

    Valhalla, New York, 10595

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta

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.

Being tested
GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device), Surgery
Keywords
Ascending Aorta, Pseudoaneurysm, Aortic Lesion, Endovascular Repair, Aortic Aneurysm, Thoracic
Medical subject headings
Aortic Aneurysm, Thoracic, Aneurysm, False, Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE® Ascending Stent Graft (ASG device)Device

    Endovascular aortic repair of the ascending aorta

  • GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)Device

    Also called Revascularization Procedure

    Endovascular aortic repair of the ascending aorta/aortic arch

  • SurgeryProcedure or surgery

    Open surgical repair of the ascending aorta and/or the aortic arch

Study groups in NCT05800743
Study groupRoleWhat they receive
ASG device only in Ascending AortaExperimentalAscending 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.
Receives: Device: GORE® Ascending Stent Graft (ASG device)
ASG + TBEExperimentalAscending 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.
Receives: Device: GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)
Surgical Follow-up CohortOtherOpen surgical repair of ascending aorta in subjects at high-risk for surgical repair
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 Days

  2. 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

    Measured: 30 Days

Secondary outcomes (2)

  1. Secondary endpoints as measured as a composite of procedural and treatment success.

    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

    Measured: 30 Days, and 6, 12, 24, 36, 48 and 60 months

  2. Secondary endpoint as measured by Short Form-36® physical component summary (PCS)

    Short Form-36® PCS measured at the one year follow-up visit with inferential analysis

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start28 Nov 2023
  3. Primary completionOct 2029 (estimated)
  4. Study completionJan 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800743
Sponsor's protocol ID
ASG 22-02
Acronym
ARISEII
Status last verified
May 2026
First submitted
23 Mar 2023
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device) and Surgery in people with Aortic Aneurysm, Thoracic and Pseudoaneurysm, run by W.L.Gore & Associates at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 64 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary effectiveness endpoint as measured by device technical success and absence of reintervention. (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05800743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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