Evaluation of the GORE® Ascending Stent Graft

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection, Aorta; Lesion

Intervention / Treatment
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* Device: GORE® Ascending Stent Graft (ASG device)
* Device: GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASG device only in Ascending Aorta<br>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. | Device: GORE® Ascending Stent Graft (ASG device)<br>* Endovascular aortic repair of the ascending aorta<br>|
| Experimental: ASG + TBE<br>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. | Device: GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)<br>* Endovascular aortic repair of the ascending aorta/aortic arch<br>* Other names: Revascularization Procedure;|
| Other: Surgical Follow-up Cohort<br>Open surgical repair of ascending aorta in subjects at high-risk for surgical repair | Procedure: Surgery<br>* Open surgical repair of the ascending aorta and/or the aortic arch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 Days, and 6, 12, 24, 36, 48 and 60 months | 
| 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ascending Aorta, Pseudoaneurysm, Aortic Lesion, Endovascular Repair, Aortic Aneurysm, Thoracic