Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts (NCT02323581) | Clinical Trial Compass
RecruitingNot Applicable
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
United States520 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Presence of TAAA in:
ā. Men with TAAA greater than or equal to 6 cm in diameter
ā. Women with TAAA greater than or equal to 5 cm in diameter
ā. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
ā. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
ā. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
ā. Life expectancy more than 2 years
ā. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
Exclusion criteria
ā. Rupture, with hypotension (systolic bp \< 90).
ā. Pregnancy or breastfeeding.
ā. Unwillingness or inability to comply with the follow up schedule.
ā. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).