search
Back to results

Evaluation of the GORE® Ascending Stent Graft (ARISEII)

Primary Purpose

Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GORE® Ascending Stent Graft (ASG device)
GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)
Surgery
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Thoracic focused on measuring Ascending Aorta, Pseudoaneurysm, Aortic Lesion, Endovascular Repair, Aortic Aneurysm, Thoracic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASG Device Alone Arm 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 (≥55mm 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. 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 Exclusion Criteria: ASG Device Alone Arm 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 factor that could increase the risk of stroke based on Gore Imaging Sciences 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 Inclusion Criteria: ASG + TBE Device Arm 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 aorta that cannot be heavily calcified, or heavily thrombosed Distal Aortic Landing Zone: Outer curvature length 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 Exclusion Criteria: ASG + TBE Device Arm 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 factor that could increase the risk of stroke based on Gore Imaging Sciences 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 Inclusion Criteria: Surgical Follow-up Cohort 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    ASG device only in Ascending Aorta

    ASG + TBE

    Surgical Follow-up Cohort

    Arm Description

    Ascending 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.

    Ascending 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.

    Open surgical repair of ascending aorta in subjects at high-risk for surgical repair

    Outcomes

    Primary Outcome Measures

    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: Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, and; Accurate placement of the device at the intended implantation site, and 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.
    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 Outcome Measures

    Secondary endpoints as measured as a composite of procedural and treatment success.
    Two secondary endpoints are planned for the study. 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

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    April 10, 2023
    Sponsor
    W.L.Gore & Associates
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05800743
    Brief Title
    Evaluation of the GORE® Ascending Stent Graft
    Acronym
    ARISEII
    Official Title
    Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2029 (Anticipated)
    Study Completion Date
    January 2034 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    W.L.Gore & Associates

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection, Aorta; Lesion
    Keywords
    Ascending Aorta, Pseudoaneurysm, Aortic Lesion, Endovascular Repair, Aortic Aneurysm, Thoracic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    370 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ASG device only in Ascending Aorta
    Arm Type
    Experimental
    Arm Description
    Ascending 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.
    Arm Title
    ASG + TBE
    Arm Type
    Experimental
    Arm Description
    Ascending 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.
    Arm Title
    Surgical Follow-up Cohort
    Arm Type
    Other
    Arm Description
    Open surgical repair of ascending aorta in subjects at high-risk for surgical repair
    Intervention Type
    Device
    Intervention Name(s)
    GORE® Ascending Stent Graft (ASG device)
    Intervention Description
    Endovascular aortic repair of the ascending aorta
    Intervention Type
    Device
    Intervention Name(s)
    GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)
    Other Intervention Name(s)
    Revascularization Procedure
    Intervention Description
    Endovascular aortic repair of the ascending aorta/aortic arch
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery
    Intervention Description
    Open surgical repair of the ascending aorta and/or the aortic arch
    Primary Outcome Measure Information:
    Title
    Primary effectiveness endpoint as measured by device technical success and absence of reintervention.
    Description
    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: Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, and; Accurate placement of the device at the intended implantation site, and 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
    Time Frame
    30 Days
    Title
    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.
    Description
    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
    Time Frame
    30 Days
    Secondary Outcome Measure Information:
    Title
    Secondary endpoints as measured as a composite of procedural and treatment success.
    Description
    Two secondary endpoints are planned for the study. 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
    Time Frame
    30 Days, and 6, 12, 24, 36, 48 and 60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASG Device Alone Arm 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 (≥55mm 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. 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 Exclusion Criteria: ASG Device Alone Arm 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 factor that could increase the risk of stroke based on Gore Imaging Sciences 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 Inclusion Criteria: ASG + TBE Device Arm 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 aorta that cannot be heavily calcified, or heavily thrombosed Distal Aortic Landing Zone: Outer curvature length 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 Exclusion Criteria: ASG + TBE Device Arm 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 factor that could increase the risk of stroke based on Gore Imaging Sciences 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 Inclusion Criteria: Surgical Follow-up Cohort 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clinical Study Manager
    Phone
    800-437-8181
    Email
    ARISE2PIVOTAL@wlgore.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric Roselli, MD
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the GORE® Ascending Stent Graft

    We'll reach out to this number within 24 hrs