Branched Aortic Arch Study

NCT ID: NCT00488696

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2025-09-30

Brief 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.

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.

Conditions

Aortic Aneurysm of the Proximal Arch

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

Endovascular Bifurcated Stent Graft: The investigational operation involves placing a stent-graft over the aortic aneurysm.

Group Type: EXPERIMENTAL

Endovascular Bifurcated Stent-Graft

Intervention Type: DEVICE

Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.

Interventions

Endovascular Bifurcated Stent-Graft

Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.

Intervention Type: DEVICE

Eligibility Criteria

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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Timothy Chuter, MD

OTHER

Sponsor Role: lead

Responsible Party

Timothy Chuter, MD

Sub-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Linda M Reilly, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Division of Vascular and Endovascular Surgery

San Francisco, California, United States

Countries

United States

References

Svensson LG, Crawford ES, Hess KR, Coselli JS, Raskin S, Shenaq SA, Safi HJ. Deep hypothermia with circulatory arrest. Determinants of stroke and early mortality in 656 patients. J Thorac Cardiovasc Surg. 1993 Jul;106(1):19-28; discussion 28-31.

Reference Type: BACKGROUND

PMID: 8321002 (View on PubMed)

Ergin MA, Griepp EB, Lansman SL, Galla JD, Levy M, Griepp RB. Hypothermic circulatory arrest and other methods of cerebral protection during operations on the thoracic aorta. J Card Surg. 1994 Sep;9(5):525-37. doi: 10.1111/j.1540-8191.1994.tb00886.x.

Reference Type: BACKGROUND

PMID: 7994095 (View on PubMed)

Criado FJ, Barnatan MF, Rizk Y, Clark NS, Wang CF. Technical strategies to expand stent-graft applicability in the aortic arch and proximal descending thoracic aorta. J Endovasc Ther. 2002 Jun;9 Suppl 2:II32-8.

Reference Type: BACKGROUND

PMID: 12166839 (View on PubMed)

Saccani S, Nicolini F, Beghi C, Marcato C, Uccelli M, Larini P, Budillon AM, Agostinelli A, Gherli T. Thoracic aortic stents: a combined solution for complex cases. Eur J Vasc Endovasc Surg. 2002 Nov;24(5):423-7. doi: 10.1053/ejvs.2002.1687.

Reference Type: BACKGROUND

PMID: 12435342 (View on PubMed)

Chuter TA, Buck DG, Schneider DB, Reilly LM, Messina LM. Development of a branched stent-graft for endovascular repair of aortic arch aneurysms. J Endovasc Ther. 2003 Oct;10(5):940-5. doi: 10.1177/152660280301000517.

Reference Type: BACKGROUND

PMID: 14656176 (View on PubMed)

Schneider DB, Curry TK, Reilly LM, Kang JW, Messina LM, Chuter TA. Branched endovascular repair of aortic arch aneurysm with a modular stent-graft system. J Vasc Surg. 2003 Oct;38(4):855. doi: 10.1016/s0741-5214(03)01024-3. No abstract available.

Reference Type: BACKGROUND

PMID: 14560244 (View on PubMed)

Other Identifiers

10-03930

Identifier Type: -

Identifier Source: org_study_id