Aortic Aneurysm, Thoracic, Aortic Aneurysm, Thoracoabdominal, Aortic Dissection, Thoracoabdominal
Conditions
Keywords
Thoracoabdominal, Aneurysm, Endovascular, Stent-Graft, Aortic Arch, BEVAR, FEVAR, Aorta, Aortic Dissection
Brief summary
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
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: 1. 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. 2. Aortic Arch Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using 1) physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches 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.
Interventions
DEVICEEndovascular treatment of Thoracoabdominal Aortic Aneurysm
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.
DEVICEEndovascular treatment of Aortic Arch Aneurysms
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.
Sponsors
Darren Schneider, M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
TAAA STUDY ARM Inclusion Criteria: 1. Presence of TAAA in: 1. Men with TAAA greater than or equal to 6 cm in diameter 2. Women with TAAA greater than or equal to 5 cm in diameter 3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year 4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or 5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter 2. Life expectancy more than 2 years 3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol 4. Suitable arterial anatomy for endovascular TAAA repair with TAAA device: 1. Proximal aortic landing zone: * ≥ 20mm long * ≤ 40mm and ≥ 20mm diameter in parallel aorta * free from circumferential thrombus * ≤ 60 degrees angulation 2. Mesenteric/renal aortic diameter ≥ 20mm 3. Mesenteric arteries: * ≥ 10mm long segment of healthy artery for branch attachment * Diameter ≥ 4mm and ≤ 12mm * Absence of aberrant or early branching, aneurysm or dissection 4. Renal arteries: * ≥ 10mm long segment of healthy artery for branch attachment * Diameter ≥ 4mm and ≤ 8mm * Absence of aberrant or early branching, aneurysm or dissection 5. Iliac artery access: * ≥ 6mm diameter, and absence of severe calcification and tortuosity * Or, planned creation of surgical conduit for TAAA device delivery 6. 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 5. Patients deemed high risk for open repair (meeting one, or more, of the following criteria): 1. Age ≥ 65 year 2. 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) 3. Pulmonary disease: * Home oxygen therapy * FEV1 \< 1.2 l/s * Vital capacity \< 50% predicted * PaCO2 \> 45 mm Hg or \< 60 mm Hg 4. Renal disease: * ESRD on dialysis * eGFR \< 60 5. Prior aortic surgery 6. Hostile abdomen 7. Portal hypertension (ascites or varices) 8. Coagulopathy AORTIC ARCH STUDY ARM Inclusion Criteria: 1. Presence of aortic arch aneurysm in: 1. Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or 2. Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or 3. Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or 4. Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or 5. Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation 2. Life expectancy more than 2 years 3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol. 4. Suitable arterial anatomy for endovascular aortic arch repair with Aortic Arch Device: 1. Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass 2. 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 3. 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 4. 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 5. Iliac artery access: * ≥ 6mm diameter, and absence of severe calcification and tortuosity * Or, planned creation of surgical conduit for TAAA device delivery 5. 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): 1. Age \> 70 years-old 2. Prior ascending or aortic arch repair 3. Multiple (≥2) median sternotomies 4. Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test 5. Chronic pulmonary disease with FEV1 \< 1500ml 6. Chronic kidney disease with eGFR ≤ 60 ml/kg/hr 7. Large aneurysm abutting the sternotomy 8. Severe deconditioning or immobility 9. Prior cervical irradiation 10. 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
1. Rupture, with hypotension (systolic bp \< 90). 2. Pregnancy or breastfeeding. 3. Unwillingness or inability to comply with the follow up schedule. 4. Serious systemic or groin infection. 5. Uncorrectable coagulopathy. 6. Age \< 18 years. 7. Mycotic aneurysm. 8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft). 9. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold. 10. Participation in another in another investigational device or drug study within 1 year of treatment. 11. 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) 12. Body habitus that would inhibit X-ray visualization of the aorta. 13. Acute aortic dissection 14. Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Intraoperative | 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 |
| Procedural Success | 30 days | 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. |
| Freedom from aneurysm-related mortality at 1 year | 1 year | Survival from aneurysm-related death. |
| Treatment success at 12 months post-procedure | 1 year | Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from aneurysm dilatation | Yearly through 5 years | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size. |
| Freedom from serious adverse events (SAE) and major complications | Yearly through 5 years | 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. |
| Freedom from aneurysm rupture and conversion to open repair | Yearly through 5 years | 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. |
| Freedom from stent graft migration and branch device migration | Yearly through 5 years | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks. |
| Freedom from major stroke | Yearly through 5 years | 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. |
| Target artery patency | Yearly through 5 years | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency. |
| Freedom from onset permanent hemodialysis | Yearly through 5 years | 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. |
| Freedom from amputation | Yearly through 5 years | 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. |
| Freedom from bowel infarction | Yearly through 5 years | 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. |
| Freedom from loss of target vessel patency | Yearly through 5 years | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks. |
| Freedom from paralysis | Yearly through 5 years | 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. |
| Freedom from all-cause mortality | Yearly through 5 years | 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. |
| Freedom from reintervention | Yearly through 5 years | 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. |
| Freedom from endoleak | Yearly through 5 years | Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks. |
Countries
United States
Contacts
Primary ContactDarren Schneider, MD
Backup ContactKiera Zehner
Outcome results
None listed