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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

June 18, 2007
May 22, 2014
October 2006
September 2016   (final data collection date for primary outcome measure)
Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00488696 on ClinicalTrials.gov Archive Site
Stability of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Branched Aortic Arch Study
Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm of the Proximal Arch
Device: Endovascular Bifurcated Stent-Graft
Treatment of Aneurysm involving the proximal aortic arch with endovascular bifurcated stent-graft.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
September 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Timothy AM Chuter, MD 415-353-4366
Contact: Linda M Reilly, MD 415-353-4366
United States
 
NCT00488696
10-03930
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Linda M Reilly, MD Professor of Surgery
University of California, San Francisco
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP