Branched Aortic Arch Study
a study on Aneurysm
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.
Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch
An aneurysm is a localized bulge in the wall of an artery. Aneurysms of the aorta are prone to progressive dilatation, which if left untreated ultimately results in rupture, internal bleeding and death. Traditional open surgery involves aortic exposure through a long incision, aortic clamping to interrupt blood flow, and replacement or repair of the dilated aortic segment using a fabric conduit (graft), which is sutured (anastomosis) to the nondilated arteries above and below the aneurysm. Some subjects are able to withstand such a large operation better than others, but many suffer complications, and all suffer pain, debility, and a lengthy stay in hospital.
Endovascular aneurysm repair is a less invasive alternative that substitutes a trans-arterial route to the aneurysm for direct exposure, and stent-mediated attachment for sutured anastomosis. Compared to open surgical repair, endovascular repair is associated with less physiological derangement, less pain, less blood loss, lower complication rates and shorter hospital stay. Consequently, endovascular repair has become standard therapy for aneurysms of the abdominal aorta and descending thoracic aorta, where there are no vital branches and endovascular exclusion rarely causes ischemic complications.
Open surgical repair of the proximal aortic arch requires hypothermic circulatory arrest, because it deprives the heart of its outflow and the brain of its inflow. Endovascular repair also obstructs outflow from the heart, but only for a few seconds, while the graft is released from its delivery sheath. The greater problem is inflow to the brain. In anticipation of aortic arch exclusion, the brachiocephalic circulation requires an alternative source of blood. One alternative is bypass from the ascending aorta. However, this requires median sternotomy and partial aortic clamping, both of with are potential sources of morbidity.
Aortic Aneurysm of the Proximal Arch Aneurysm Aortic Arch Endovascular Stent-Graft
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- Free rupture of the aneurysm
- Anaphylactic reaction to contrast material
- Allergy to stainless steel or polyester
- Unwillingness or inability to comply with the follow-up schedule
- Serious systemic or groin infection
- Uncorrectable coagulopathy
- Significant presence of carotid artery atherosclerosis
- 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.
- UCSF Division of Vascular and Endovascular Surgery accepting new patients
San Francisco, California, 94143, United States
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT00488696.