Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Study Overview
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Brief Summary
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Prospective, non-randomized, , multicenter study with two independent arms: Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)

Official Title
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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

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 defined as at least one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (≥ 5 mm in one year) Aortic aneurysm that involves the abdominal aorta, with: Involvement of at least one visceral vessel and aneurysmal extension as far as 65 mm proximal to the celiac artery, and/or No normal aorta between the upper extent of aneurysm and renal artery(s) Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required) Age ≥ 19 years at the time of informed consent signature Male or infertile female Patient assessment favors an endovascular approach when compared to open surgical 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 Sufficient distal landing zones in both iliac arteries, with at least one patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery. Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following: For the TAMBE aortic component, proximal aortic landing zone diameters between 22-34 mm Proximal seal zone ≥ 20 mm in length Aortic neck angle ≤ 60° Distal landing zone (iliac arteries) 8-25 mm Distal seal zone in iliac arteries of at least 10 mm in length Renal artery landing zone diameters between 4-10 mm Celiac and superior mesenteric artery landing zone diameters between 5-12 mm ≥ 15 mm landing zone in each branch vessel Landing zones in the proximal and distal aorta and all branch vessels cannot be aneurysmal, heavily calcified, or heavily thrombosed Patent left subclavian artery Secondary Study Arm Only: If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a CTAG Device is required. The aortic landing zone diameter treatment range with the CTAG Device is 19.5-32 mm The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery. The most proximal aortic device seal zone will be within native aorta or a previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another device manufacturer's stent graft will not be supported Exclusion Criteria: The patient is / has: Prior open, aortic surgery of the ascending aorta or aortic arch 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 1 year of treatment (staged or index procedure) Systemic infection which may increase risk of endovascular graft infection Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome Participation in an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening 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 A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow 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 (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing dialysis) Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment

Ages Eligible for Study
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Minimum Age: 19 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
Interventional Model Description: This study contains two single arm substudies. A primary study arm and a secondary study arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary Study Arm<br>TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102) | Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis<br>* Endovascular Aortic Stent-Graft<br>* Other names: TAMBE;|
| Experimental: Secondary Study Arm<br>TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100) | Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis<br>* Endovascular Aortic Stent-Graft<br>* Other names: TAMBE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects with Uncomplicated Technical Success and freedom from Procedural Safety Composite Event | Percent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event. Device Technical Success Composite Events: Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal Procedural Safety: Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabling Stroke | Index Procedure and Within 30 Days of Index Procedure | 
| Percent of Subjects free from Clinically Significant Reintervention / Lesion-Related Mortality Co-Primary Endpoint Events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects with Aneurysm-related mortality |  | 30 days | 
| Percent of Subjects with Stented Segment Aortic Rupture |  | 30 days | 
| Percent of Subjects with Lesion Related Mortality |  | 30 days | 
| Percent of Subjects with Permanent Paraplegia |  | 30 days | 
| Percent of Subjects with Permanent Paraparesis |  | 30 days of index procedure | 
| Percent of Subjects with New Onset Renal Failure Requiring Dialysis |  | 30 days | 
| Percent of Subjects with Severe Bowel Ischemia |  | 30 days | 
| Percent of Subjects with Disabling Stroke | Stroke will be assessed using the Modified Rankin Scale. Stroke identified as having occurred within 30 days of the index endovascular procedure, combined with mRS ≥2 with an increase from baseline of at least one grade at 90 days. Modified Rankin Scale: 0 - No Symptoms No significant disability. Able to carry out all usual activities, despite some symptoms Slight Disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate Disability. Requires some help, but able to walk unassisted Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe Disability. Requires constant nursing care and attention, bedridden, incontinent Dead Higher Values are worse. A total score will not be computed, but a change from baseline will be calculated as (90 Day Post-Stroke MRS Score - Baseline MRS Score) | 120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score) | 
| Percent of Subjects with Access-Related Complications |  | 30 days of index procedure | 
| Mean Procedural Blood Loss at Index Procedure |  | Index Procedure | 
| Procedure Time |  | Index Procedure | 
| Length of Hospital Stay |  | 12 months | 
| Percent of Subjects with Extended Technical Clinical Success | Patients who present within the 30-Day follow-up with no Type I or Type III endoleak, as evaluated by CTA, and free from device-related intervention. | 30 days | 
| Percent of Subjects with Type I Endoleak | Endoleak arising from the proximal or distal sealing zone of a device perfusing the aneurysm Type IA: Inadequate seal at the proximal end of the device placed in the aorta Type IB: Inadequate seal at the distal end of the device placed in iliac vessel Type IC: Inadequate seal at the distal end of a device placed inside branch vessel Reported as ratio with the number of subjects with Type I Endoleak as numerator, number of subjects with an evaluable result as denominator. Ratios of Type IA, IB, and IC will also be reported. | 12 Months | 
| Percent of Subjects with Type II Endoleak | Endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. | 12 Months | 
| Percent of Subjects with Type III Endoleak | Type III Endoleak through 12 months - Endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material perfusing the aneurysm. Type III General: A Type III endoleak whose source cannot be differentiated between an intercomponent junction or graft tear Type IIIA: Modular disconnection or apposition failure Type IIIB: Graft tear | 12 Months | 
| Percent of Subjects with Type IV Endoleak | Endoleak of whole blood through the graft fabric perfusing the aneurysm Reported as a ratio. Numerator: Number of Subjects with Type IV Endoleak. Denominator: Number of Subjects with an Evaluable Result | 12 Months | 
| Percent of Subjects with Type IV Indeterminate Endoleak | Endoleak perfusing the aneurysm without a definitive source Reported as a ratio. Numerator: Number of Subjects with Type IV Endoleak. Denominator: Number of Subjects with an Evaluable Result | 12 Months | 
| Percent of Subjects with Device Migration | Longitudinal movement of all or part of the device for a distance ≥10 mm, as confirmed by CT scan, relative to anatomical landmarks and device positioning at the first post-operative CT scan | 12 Months | 
| Percent of Subject with Thoracoabdominal Aneurysm (TAAA) Enlargement | An increase in the maximum aneurysm diameter of 5 mm or more relative to the first post-operative CT scan within the 30 day follow-up window | 12 Months | 
| Percent of Subjects with Severe Distal Thromboembolic Events |  | 12 Months | 
| Percent of Subjects with Aortic Rupture |  | 12 Months | 
| Percent of Subjects with Device or procedure-related laparotomy |  | 12 Months | 
| Percent of Subjects with Conversion to Open Repair |  | 12 Months | 
| Percent of Subjects with Aortoiliac device limb occlusion |  | 12 Months | 
| Percent of Subjects with Loss of device integrity | Defined as any of the following: Wire fracture identified in the sealing row stents of either the aortic, branch or iliac components Transient (compression) or permanent stent-graft collapse (invagination) following complete device deployment, resulting in an overall reduction in the aortic, branch or iliac vessel luminal diameter | 12 Months | 
| Percent of Subjects with Reintervention | An additional unanticipated interventional or surgical procedure (including conversion to open surgery), related to the device (including withdrawal of the delivery system) or procedure. | 12 Months | 
| Percent of Subjects with Primary Patency | Blood flow without occlusion maintained through the device after implant without an intervention. Assisted Primary Patency through 12 Months- Blood flow maintained through the device after implant regardless of re-interventions performed (without occlusion) | 12 Months | 
| Percent of Subjects with Secondary Patency | Blood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass | 12 Months | 
| Percent of Subjects with Acute Kidney Injury | >50% decrease in eGFR within 30 day follow-up window of TAMBE Device treatment when compared to pre-treatment serum creatinine value. | 30 Days | 
| Percent of Subjects with Renal function deterioration | A sustained >25% decrease in eGFR over two consecutive study visits following TAMBE Device treatment when compared to pre-treatment serum creatinine value | 12 Months |