New York, New York 10022


Purpose:

Prospective, nonrandomized, single-center, single-arm feasibility and safety study to assess the feasibility and safety of endovascular stent-graft implantation using a standard configuration branched and fenestrated stent graft (TAAA device) or physician-specified branched and fenestrated stent grafts (Physician-Specified TAAA Devices) for treatment of thoracoabdominal aortic aneurysms (TAAA) involving the mesenteric and renal arteries in patients at high risk for open surgery.


Criteria:

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 4cm in diameter. 2. Life expectancy more than 2 years. 3. Ability to give informed consent and willing to comply with the follow-up schedule. 4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device": a) Proximal aortic landing zone: i) ≥ 20mm long ii) ≤ 40mm and ≥ 20mm diameter in parallel aorta iii) free from circumferential thrombus iv) ≤ 60 degrees angulation b) Mesenteric/renal aortic diameter ≥ 20mm c) Mesenteric arteries: i) ≥ 10mm long segment of healthy artery for branch attachment ii) Diameter ≥ 4mm and ≤ 12mm iii) Absence of aberrant or early branching, aneurysm or dissection d) Renal arteries: i) ≥ 10mm long segment of healthy artery for branch attachment ii) Diameter ≥ 4mm and ≤ 8mm iii) Absence of aberrant or early branching, aneurysm or dissection e) Iliac artery access: i) ≥ 6mm diameter, and absence of severe calcification and tortuosity ii) Or, planned creation of surgical conduit for TAAA device delivery f. 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): i. ≥ 10mm long segment of healthy internal iliac artery for branch attachment ii. Internal iliac diameter ≥ 5mm and ≤ 12mm iii. External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity iv. Minimum common iliac artery luminal diameter ≥ 14mm v. 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): a) Age ≥ 65 year b) Cardiac disease i) CAD (history of MI or angina with positive stress test and not revascularizable) ii) LV Ejection fraction < 40% iii) Symptomatic CHF (NYHC Class II, III, or IV) c) Pulmonary disease i) Home oxygen therapy ii) FEV1 < 1.2 l/s iii) Vital capacity < 50% predicted iv) PaCO2 > 45 mm Hg or < 60 mm Hg d) Renal disease i) ESRD on dialysis ii) eGFR < 60 e) Prior aortic surgery f) Hostile abdomen g) Portal hypertension (ascites or varices) h) Coagulopathy Exclusion Criteria: 1. Free rupture of the aneurysm. 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 or ruptured aneurysm. 8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome. 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) i) Body habitus that would inhibit X-ray visualization of the aorta.


NCT ID:

NCT02323581


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New York, New York 10022
United States

Ruchita Mehta, MS
Phone: 212-746-5949
Email: rum2006@med.cornell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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