What this study is
This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.
What's being tested
- Endovascular Branched Stent-Graft
Intervention · DEVICE
Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
Study details
- Sponsor
- Warren J. Gasper, MD
- Conditions
- Thoracoabdominal Aortic Aneurysm · Paravisceral Abdominal Aortic Aneurysm
- Enrolling
- 250 people
- Starts
- 2005-05
- Est. completion
- 2027-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Aortic aneurysms:; greater than or equal to 6 cm in diameter in men,; greater than or equal to 5.5 cm in diameter in women,; and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,; and/or iliac aneurysms larger than 4 cm in diameter.
- Anticipated mortality comparable to published rates with conventional surgical treatment.
- Life expectancy more than 2 years.
- Ability to give informed consent.
- Willingness to comply with follow-up schedule.
- Suitable arterial anatomy for endovascular repair.
You can't join if
- Free rupture of the aneurysm.
- Pregnancy.
- Known allergy to Nitinol, stainless steel, or polyester.
- Unwillingness or inability to comply with the follow up schedule.
- Serious systemic or groin infection.
- Uncorrectable coagulopathy.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Warren J Gasper, MD · Principal investigator
- Linda M Reilly, MD · Sub-investigator
Division of Vascular Surgery, SFVAMC
San Francisco, California, United States
RecruitingDivision of Vascular Surgery, UCSF
San Francisco, California, United States
- Timothy AM Chuter, MD · Sub-investigator
- Jade S Hiramoto, MD · Sub-investigator
- Shant M Vartanian, MD · Sub-investigator
Recruiting
Study team
Sponsor
Warren J. Gasper, MD
Study ID 10-02810
Principal investigator
Warren J Gasper, MD
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.