Endovascular treatment for aortic aneurysms in the proximal aortic arch
Branched Stent-Graft Repair for Endo Repair of Aneurysms Involving the Proximal Aortic Arch
NA · University of California, San Francisco · NCT00488696
This study is testing a less invasive way to treat aortic aneurysms in the upper part of the aorta using a stent-graft to see if it is safer and leads to quicker recovery than traditional surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT00488696 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of an endovascular approach to treat aortic aneurysms located in the proximal aortic arch. The procedure involves placing a stent-graft over the aneurysm, which is a less invasive alternative to traditional open surgery. By utilizing a trans-arterial route, the study aims to reduce complications, pain, and hospital stay associated with conventional surgical methods. Participants will be monitored for outcomes related to the stent-graft's performance and overall patient health.
Who should consider this trial
Good fit: Ideal candidates include individuals with aortic arch aneurysms larger than 6cm or symptomatic aneurysms with a high estimated rupture risk.
Not a fit: Patients with free rupture of the aneurysm or significant comorbidities that complicate the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risks and recovery time associated with treating aortic aneurysms.
How similar studies have performed: Other studies have shown success with endovascular approaches for similar conditions, indicating a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- UCSF Division of Vascular and Endovascular Surgery — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Linda M Reilly, MD — University of California, San Francisco
- Study coordinator: Linda M Reilly, MD
- Email: linda.reilly2@ucsf.edu
- Phone: 415-353-4366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Aneurysm of the Proximal Arch, Aneurysm, Aortic Arch, Endovascular, Stent-Graft