Branched Aortic Arch Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00488696
First received: June 18, 2007
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Aortic Aneurysm of the Proximal Arch
Device: Endovascular Bifurcated Stent-Graft
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stability of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: October 2006
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endovascular Bifurcated Stent-Graft
    Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488696

Contacts
Contact: Timothy AM Chuter, MD 415-353-4366
Contact: Linda M Reilly, MD 415-353-4366

Locations
United States, California
UCSF Division of Vascular and Endovascular Surgery Recruiting
San Francisco, California, United States, 94143
Contact: Timothy AM Chuter, MD    415-353-4366      
Principal Investigator: Linda M Reilly, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Linda M Reilly, MD Professor of Surgery
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00488696     History of Changes
Other Study ID Numbers: 10-03930
Study First Received: June 18, 2007
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Aneurysm
Aortic Arch
Endovascular
Stent-Graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 19, 2014