ARISEII: Evaluation of the GORE® Ascending Stent Graft

Sponsor

W.L.Gore & Associates (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05800743

Collaborator

(none)

370

Enrollment

Arms

123

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Thoracic Pseudoaneurysm Aortic Dissection Aorta; Lesion	Device: GORE® Ascending Stent Graft (ASG device) Device: GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) Procedure: Surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

370 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2029

Anticipated Study Completion Date :

Jan 1, 2034

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASG device only in Ascending Aorta 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) Endovascular aortic repair of the ascending aorta
Experimental: ASG + TBE 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® TAG® Thoracic Branch Endoprosthesis (TBE Device) Endovascular aortic repair of the ascending aorta/aortic arch Other Names: Revascularization Procedure
Other: Surgical Follow-up Cohort Open surgical repair of ascending aorta in subjects at high-risk for surgical repair	Procedure: Surgery Open surgical repair of the ascending aorta and/or the aortic arch

Arm

Intervention/Treatment

Experimental: ASG device only in Ascending Aorta

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)

Endovascular aortic repair of the ascending aorta

Experimental: ASG + TBE

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® TAG® Thoracic Branch Endoprosthesis (TBE Device)

Endovascular aortic repair of the ascending aorta/aortic arch

Other Names:

Revascularization Procedure

Other: Surgical Follow-up Cohort

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

Procedure: Surgery

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

Outcome Measures

Primary Outcome Measures

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: 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. [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 Outcome Measures

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. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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