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Bifurcated Stent-Graft for Endovascular Repair of Aneurysms Involving the Proximal Aortic Arch
Official Title:
Bifurcated Stent-Graft for Endovascular Repair of Aneurysms Involving the Proximal Aortic ArchBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 1/Phase 2 | Interventional | N/A and older | University of California, San Francisco |
H9065-28979 NCT00488696 |
Recruiting |
Study Design:
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Trial Summary
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- Free rupture of the aneurysm
- Pregnancy
- 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
Detailed Description
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.
Important
Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.
For More Information
For questions about this trial or eligibility, please contact:
Leyla Herrera
Clinical Research Coordinator
UCSF Vascular Surgery
415-353-4367 Office
415-353-4370 Fax
Leyla.Herrera@ucsfmedctr.org
Johanna Garcia
Clinical Research Coordinator
UCSF Vascular Surgery
415-353-4379 Office
415-353-4370 Fax
Johanna.Garcia@ucsfmedctr.org