About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Rupture, with hypotension (systolic bp < 90).

Pregnancy or breastfeeding.

Unwillingness or inability to comply with the follow up schedule.

Serious systemic or groin infection.

Trial design

Treatments tested in this trial

  • Endovascular treatment of Thoracoabdominal Aortic Aneurysm
  • Endovascular treatment of Aortic Arch Aneurysms

Treatment groups

520 Participants
are divided into 2 treatment groups

Locations

2
New York Presbyterian Hospital10022, New YorkNew York, United States
Hospital of the University of Pennsylvania19104, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

Darren Schneider, M.D.

Lead sponsor

University of Pennsylvania

Sponsor institution