Visceral Manifold Study for the Repair of TAAA

Study Overview
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Brief Summary
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The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study. The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.

Detailed Description
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This study is a prospective, single-center, non-randomized, single-arm study to evaluate the therapeutic benefit of the TAAA Debranching Stent Graft System. A total of 15 patients will be enrolled in the study. 10 subjects total will be treated in the primary study arm 5 subjects total will be treated in the expanded selection arm The duration of the Investigation is anticipated as follows: Time to Complete Enrollment: 24 months Subject Follow-up Time: 5 years from last subject enrollment Total Duration Time: 7 years The primary objective of the clinical investigation Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety acutely (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device acutely (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year). Additionally, the study will assess technical success and treatment success at each follow-up interval.

Official Title
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Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

Conditions
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Thoracoabdominal Aortic Aneurysms

Intervention / Treatment
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* Device: TAAA Debranching Stent Graft System


Participation Criteria
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Eligibility Criteria
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Primary Study Arm Inclusion Criteria: A patient may be entered into the study if the patient has at least one of the following: An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements Aneurysm with a history of growth > 0.5 cm in 6 months Saccular aneurysm deemed at significant risk for rupture Symptomatic aneurysm greater than 4.5 cm Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit Proximal landing zone for the thoracic bifurcation stent graft that has: ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold Minimum branch vessel diameter greater than 5 mm Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm Age: ≥ 18 years old Life expectancy: > 1 year Exclusion Criteria: General exclusion Patient is a good candidate for and elects for open surgical repair Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site Unwilling to comply with the follow-up schedule Inability or refusal to give informed consent Urgent or emergent presentation Patient is pregnant or breastfeeding Patient has a contained rupture Patient has a ruptured aneurysm Patient has a dissection in the portion of the aorta intended to be treated Obstructive stenting of any or all of the visceral vessels Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) Medical exclusion criteria Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel. Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed Uncorrectable coagulopathy Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina) Systemic or local infection that may increase the risk of endovascular graft infection Baseline creatinine greater than 2.0 mg/dL History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) Anatomical exclusion criteria Thrombus or excessive calcification within the neck of the aneurysm Anatomy that would not allow maintenance of at least one patent hypogastric artery Anatomy that would not allow primary or assisted patency of the left subclavian artery Expanded Selection Criteria Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria. Inclusion Criteria Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm: Minimum branch vessel diameter less than 5 mm Urgent or emergent presentation Patient has a contained rupture Patient has a ruptured aneurysm Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) Baseline creatinine greater than 2.0 mg/dL Anatomy that would not allow for maintenance of at least one hypogastric artery Anatomy that would not allow for primary or assisted patency of the left subclavian artery Or Patient that meets the criteria for inclusion in the primary study arm and: Would not be eligible for the primary study arm per a documented reason other than those outlined above, and Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.

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: Primary study<br>Patients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System. | Device: TAAA Debranching Stent Graft System<br>* The TAAA Debranching Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.<br>|
| Experimental: Expanded selection<br>Patients who fail to meet inclusion criteria for the primary study arm may be enrolled under the expanded selection arm and be treated with the TAAA Debranching Stent Graft System. | Device: TAAA Debranching Stent Graft System<br>* The TAAA Debranching Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects free from major adverse events | Primary safety outcome: Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke | 30 days | 
| Proportion of subjects with treatment success | Primary effectiveness outcome: Treatment success is defined as a composite of technical success and freedom from the following: aneurysm enlargement, aneurysm rupture, aneurysm-related mortality, conversion to open repair, secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with technical success |  | 5 years | 
| Proportion of subjects free from individual components of primary safety endpoint | Individual components of primary safety endpoint include: death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke | at 30 days | 
| Proportion of subjects free from paraparesis | Free from paraparesis | 30 days | 
| Proportion of subjects with treatment success | Treatment success includes freedom from: aneurysm enlargement; aneurysm-related mortality; aneurysm rupture; conversion to open repair; secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e. fracture), and patency-related events (i.e. device stenosis or occlusion and embolic events); renal failure; all-cause mortality; endoleaks; device integrity failure (e.g. fracture); patency-related events (i.e. device stenosis or occlusion and embolic events); other device-related events | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular, Stent, Graft