Branched Aortic Arch Study

NCT00488696 | Withdrawn DMC

• 1 other identifier: 10-03930
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm of the Proximal Arch

Keywords

Aneurysm; Aortic Arch; Endovascular; Stent-Graft

Outcome Measures

Primary Outcomes (1)

• Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch

  1 month

Secondary Outcomes (1)

• Stability of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch

  5 years

Study Arms (1)

Interventional

EXPERIMENTAL

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

Device: Endovascular Bifurcated Stent-Graft

Interventions

Endovascular Bifurcated Stent-Graft DEVICE

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

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Timothy Chuter, MD: lead

Study Sites (1)

UCSF Division of Vascular and Endovascular Surgery

San Francisco, California, 94143, United States

Location

Related Publications (6)

• 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.

  PMID: 8321002 BACKGROUND

• 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.

  PMID: 7994095 BACKGROUND

• 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.

  PMID: 12166839 BACKGROUND

• 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.

  PMID: 12435342 BACKGROUND

• 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.

  PMID: 14656176 BACKGROUND

• 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.

  PMID: 14560244 BACKGROUND

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Linda M Reilly, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: October 1, 2006
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)