RECRUITING

Branched Aortic Arch Study

Description

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
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Related Conditions:

Aortic Aneurysm of the Proximal Arch

Study Overview

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Study Details

Study overview

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.

Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch

Branched Aortic Arch Study

Condition
Aortic Aneurysm of the Proximal Arch
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF Division of Vascular and Endovascular Surgery, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Timothy Chuter, MD,

Linda M Reilly, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2024-12