GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

Study Overview
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Brief Summary
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This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.

Detailed Description
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This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.

Official Title
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Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels

Conditions
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Thoracoabdominal Aortic Aneurysm

Intervention / Treatment
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* Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic aneurysm involving the visceral vessels requiring treatment Adequate access for TAMBE Device components Appropriate aortic anatomy to receive the TAMBE Device Age ≥ 18 years at the time of informed consent signature Male or infertile female The patient is considered high risk for open repair as deemed by the treating physician Capable of complying with protocol requirements, including follow-up An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply Exclusion Criteria: Prior aortic surgery Ruptured or leaking aortic aneurysm Aneurysmal dilatation due to chronic aortic dissection Infected aorta Mycotic aneurysm Life expectancy <2 years Myocardial infarction or stroke within 6 weeks of treatment Systemic infection which may increase risk of endovascular graft infection Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome Participation in another drug or medical device study within 1 year of study enrollment History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access Known sensitivities or allergies to the device materials Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta Renal Insufficiency Note: Additional Exclusion Criteria may apply

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAMBE Device<br>Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled. | Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis<br>* Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)<br>* Other names: TAMBE Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL | Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL | Absence of procedural safety events through 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success, Including Individual Components of Technical Success | Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure | 12-month | 
| Device Integrity, Including Individual Components of Device Integrity | Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components | 12-month | 
| Patency (Primary, Assisted Primary, and Secondary) | Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass. | 12-month | 
| Absence of Type I and Type III Endoleaks at One Month Follow-up | Absence of Type I and Type III endoleaks | One Month followup |