Branched Aortic Arch Study
Reason given: The study team was unable to identify eligible subjects. The study is being closed out due to a lack of subject eligibility. Zero subjects were enrolled in the entire duration of the study.
Key facts
- Where
- San Francisco, United StatesSee the site
Where in United States
- UCSF Division of Vascular and Endovascular SurgerySan Francisco, United StatesNo longer taking part
Trial details
- Who runs it
- Timothy Chuter, MD
- Trial code
- NCT00488696
- Record updated
- 16 December 2025
- Original description
This is a study to assess the safety and effectiveness of endovascular treatment of aortic aneurysms involving the proximal aortic arch. The investigational operation involves placing a stent-graft over the aortic aneurysm.Read full original descriptionShow less
Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch
This is a study to assess the safety and effectiveness of endovascular treatment of aortic aneurysms involving the proximal aortic arch. The investigational operation involves placing a stent-graft over the aortic aneurysm.
Inclusion: Aneurysm of the aortic arch larger than 6cm in diameter, or symptomatic aneurysm of the aortic arch, of any diameter, or any arch aneurysm with a 2-year rupture rate estimated to be more than 20%; Anticipated mortality rate with open repair estimated to be more than 20%; Suitable arterial anatomy for stent-graft; Life expectancy more than 2 years; Ability to give informed consent and willingness to comply with follow-up schedule.
Exclusion: Allergy to stainless steel or polyester; Serious systemic or groin infection; Arrhythmia define as 2nd- and 3rd-degree atrioventricular block or sinus node disease, such as sick sinus syndrome and symptomatic bradycardia, unless the patient already has a pacemaker in place and cardiology consultation confirms that it is safe to proceed; Free rupture of the aneurysm; Pregnancy; Anaphylactic reaction to contrast material; Unwillingness or inability to comply with the follow-up schedule; Uncorrectable coagulopathy; Significant presence of carotid artery atherosclerosis.