Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Study Overview
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Brief Summary
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Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

Detailed Description
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To assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery in two study arms: TAAA (thoracoabdominal aortic aneurysm) Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using either a multibranched stent graft (Off-the-Shelf TAAA Device) or custom-manufactured physician-specified branched and/or fenestrated stent graft (Physician-Specified TAAA Device) to treat aortic aneurysms involving the mesenteric and/or renal arteries (TAAA) in patients at high risk for open surgery. Aortic Arch Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using a physician-specified aortic arch stent graft device [1) double inner branch stent-graft with or without retrograde left subclavian branch or 2) a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.

Official Title
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Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Conditions
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Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Thoracic, Aortic Dissection, Thoracoabdominal

Intervention / Treatment
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* Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm
* Device: Endovascular treatment of Aortic Arch Aneurysms


Participation Criteria
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Eligibility Criteria
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TAAA STUDY ARM Inclusion Criteria: Presence of TAAA in: Men with TAAA greater than or equal to 6 cm in diameter Women with TAAA greater than or equal to 5 cm in diameter Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter Life expectancy more than 2 years Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol Suitable arterial anatomy for endovascular TAAA repair with TAAA device: Proximal aortic landing zone: ≥ 20mm long ≤ 40mm and ≥ 20mm diameter in parallel aorta free from circumferential thrombus ≤ 60 degrees angulation Mesenteric/renal aortic diameter ≥ 20mm Mesenteric arteries: ≥ 10mm long segment of healthy artery for branch attachment Diameter ≥ 4mm and ≤ 12mm Absence of aberrant or early branching, aneurysm or dissection Renal arteries: ≥ 10mm long segment of healthy artery for branch attachment Diameter ≥ 4mm and ≤ 8mm Absence of aberrant or early branching, aneurysm or dissection Iliac artery access: ≥ 6mm diameter, and absence of severe calcification and tortuosity Or, planned creation of surgical conduit for TAAA device delivery For patients with associated common iliac artery aneurysms (>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use): ≥ 10mm long segment of healthy internal iliac artery for branch attachment Internal iliac diameter ≥ 5mm and ≤ 12mm External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity Minimum common iliac artery luminal diameter ≥ 14mm Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery Patients deemed high risk for open repair (meeting one, or more, of the following criteria): Age ≥ 65 year Cardiac disease: CAD (history of MI or angina with positive stress test and not revascularizable) LV Ejection fraction < 40% Symptomatic CHF (NYHC Class II, III, or IV) Pulmonary disease: Home oxygen therapy FEV1 < 1.2 l/s Vital capacity < 50% predicted PaCO2 > 45 mm Hg or < 60 mm Hg Renal disease: ESRD on dialysis eGFR < 60 Prior aortic surgery Hostile abdomen Portal hypertension (ascites or varices) Coagulopathy AORTIC ARCH STUDY ARM Inclusion Criteria: Presence of aortic arch aneurysm in: Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation Life expectancy more than 2 years Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol. Suitable arterial anatomy for endovascular aortic arch repair with Aortic Arch Device: Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass Proximal aortic landing zone: Native aorta or surgical graft ≥ 20 mm long ≤ 42 mm and ≥ 20 mm diameter in parallel aorta free from circumferential thrombus Distal aortic landing zone: Native aorta or surgical graft ≥ 20 mm long ≤ 42 mm and ≥ 20 mm diameter in parallel aorta free from circumferential thrombus ≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery Adequate supra-aortic trunk branch landing zone(s): Innominate artery (if applicable): Native vessel or surgical graft Diameter: 8-22mm Length of sealing zone ≥10mm Acceptable tortuosity Absence of dissection in landing zone Left (or right) common carotid artery (if applicable): Native vessel or surgical graft Diameter 6-16mm Length of sealing zone ≥10mm Acceptable tortuosity Absence of dissection in landing zone Left (or right) subclavian artery (if applicable): Native vessel or surgical graft Diameter: 5-20mm Length of sealing zone ≥10mm Acceptable tortuosity Absence of dissection in landing zone Iliac artery access: ≥ 6mm diameter, and absence of severe calcification and tortuosity Or, planned creation of surgical conduit for TAAA device delivery Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria): Age > 70 years-old Prior ascending or aortic arch repair Multiple (≥2) median sternotomies Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test Chronic pulmonary disease with FEV1 < 1500ml Chronic kidney disease with eGFR ≤ 60 ml/kg/hr Large aneurysm abutting the sternotomy Severe deconditioning or immobility Prior cervical irradiation Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery) APPLIES TO BOTH STUDY ARMS Exclusion Criteria: Rupture, with hypotension (systolic bp < 90). Pregnancy or breastfeeding. Unwillingness or inability to comply with the follow up schedule. Serious systemic or groin infection. Uncorrectable coagulopathy. Age < 18 years. Mycotic aneurysm. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft). Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold. Participation in another in another investigational device or drug study within 1 year of treatment. Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment) Body habitus that would inhibit X-ray visualization of the aorta. Acute aortic dissection Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal 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: TAAA (thoracoabdominal aortic aneurysm) Study Arm<br>Either the Off-the-Shelf TAAA device or the Physician-Specified TAAA Device will be implanted. The Off-the-Shelf TAAA Device is a standard configuration Zenith t-Branch with four branches for the mesenteric arteries and the renal arteries. The Physician-Specified TAAA Devices may include a combination of up to 5 fenestrations and branches for mesenteric and renal arteries. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards. | Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm<br>* A TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached. This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called fenestrations) that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.<br>|
| Experimental: Aortic Arch Study Arm<br>Physician-specified double inner branch stent-graft with or without retrograde left subclavian branch or a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery. | Device: Endovascular treatment of Aortic Arch Aneurysms<br>* An aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms. The arch branch endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Successful deployment of the TAAA device or Physician-Specified TAAA Devices, or Aortic Arch device & bridging covered stents into all targeted mesenteric & renal, or supra-aortic arteries with stent-graft & all branches patent by intraop angiography | Intraoperative | 
| Procedural Success | Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, & bowel infarction following deployment of the branched stent-graft. | 30 days | 
| Freedom from aneurysm-related mortality at 1 year | Survival from aneurysm-related death. | 1 year | 
| Treatment success at 12 months post-procedure | Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target artery patency | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency. | Yearly through 5 years | 
| Freedom from all-cause mortality | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation. | Yearly through 5 years | 
| Freedom from reintervention | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if reintervention with the device is necessary. | Yearly through 5 years | 
| Freedom from endoleak | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks. | Yearly through 5 years | 
| Freedom from aneurysm dilatation | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size. | Yearly through 5 years | 
| Freedom from serious adverse events (SAE) and major complications | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation. | Yearly through 5 years | 
| Freedom from aneurysm rupture and conversion to open repair | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if aneurysm stability. | Yearly through 5 years | 
| Freedom from stent graft migration and branch device migration | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks. | Yearly through 5 years | 
| Freedom from major stroke | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation. | Yearly through 5 years | 
| Freedom from paralysis | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation. | Yearly through 5 years | 
| Freedom from onset permanent hemodialysis | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation. | Yearly through 5 years | 
| Freedom from amputation | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation. | Yearly through 5 years | 
| Freedom from bowel infarction | Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation. | Yearly through 5 years | 
| Freedom from loss of target vessel patency | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks. | Yearly through 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoabdominal, Aneurysm, Endovascular, Stent-Graft, Aortic Arch, BEVAR, FEVAR, Aorta, Aortic Dissection