Thoracoabdominal aortic aneurysm: observations regarding the natural course of the disease.
E S Crawford, R W DeNatale
https://pubmed.ncbi.nlm.nih.gov/3959256Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID00483249
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Led by Warren J. Gasper, MD · Updated on 2026-03-05
250
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the safety and effectiveness of endovascular treatment for thoracoabdominal (TAAA) and paravisceral abdominal aortic aneurysms (PVAAA). These aneurysms are abnormal enlargements of the aorta in the chest and abdomen. The study compares a less invasive investigational operation to the standard open surgery, aiming to reduce pain and complications while addressing an unknown success rate of the new approach. The investigational treatment involves placing a branched stent-graft inside the aorta through small incisions in both groins and the right arm. Tubes are inserted through the femoral and brachial arteries to position the graft, which is secured with metal springs called stents. This method may offer advantages like less pain, shorter hospital stay, and fewer pulmonary or cardiac complications compared to traditional open surgery. Participants will undergo the endovascular procedure and be followed up to assess successful graft implantation after one month and long-term treatment success over five years. Researchers will monitor safety, treatment effectiveness, and patient recovery. Participants need to comply with follow-up visits and evaluations throughout the study to help determine the outcomes and potential benefits of this less invasive approach.
CONDITIONS
Brief Title
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aortic aneurysm diameter greater than or equal to 6 cm in men
- Aortic aneurysm diameter greater than or equal to 5.5 cm in women
- Aortic aneurysm larger than 5 cm and enlarging more than 5 mm per year
- Iliac aneurysms larger than 4 cm in diameter
- Anticipated mortality comparable to conventional surgical treatment
- Life expectancy more than 2 years
- Ability to provide informed consent
- Willingness to comply with follow-up schedule
- Suitable arterial anatomy for endovascular repair
You will not qualify if you...
- Free rupture of the aneurysm
- Pregnancy
- Known allergy to Nitinol, stainless steel, or polyester
- Unwillingness or inability to comply with follow-up schedule
- Serious systemic or groin infection
- Uncorrectable coagulopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Hospital stay duration (varies per participant)
Participants undergo the investigational endovascular operation where small incisions are made in both groins and the right arm to place a branched stent-graft in the aorta through tubes inserted via the femoral and brachial arteries.
1 hospital visit for the procedure
Post-operative Follow-up
Duration - Up to 5 years
Participants are monitored for the success of the stent-graft implantation and longer-term outcomes.
Regular follow-up visits with assessments over 5 years
Trial Site Locations
Total: 2 locations
1
Division of Vascular Surgery, SFVAMC
San Francisco, California, United States, 94121
Actively Recruiting
2
Division of Vascular Surgery, UCSF
San Francisco, California, United States, 94143
Actively Recruiting
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Research Team
W
Warren J Gasper, MD
M
Madeleine L Clinch
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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R P Cambria, J K Davison, C Carter...
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S R Walker, S W Yusuf, P W Wenham...
https://pubmed.ncbi.nlm.nih.gov/9867320Cardiovascular and catecholamine responses during endovascular and conventional abdominal aortic aneurysm repair.
J P Thompson, J R Boyle, M M Thompson...
https://pubmed.ncbi.nlm.nih.gov/10204055AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial.
C K Zarins, R A White, D Schwarten...
https://pubmed.ncbi.nlm.nih.gov/9950987Concurrent comparison of endoluminal versus open repair in the treatment of abdominal aortic aneurysms: analysis of 303 patients by life table method.
J May, G H White, W Yu...
https://pubmed.ncbi.nlm.nih.gov/9510276Endovascular aneurysm repair in high-risk patients.
T A Chuter, L M Reilly, R M Faruqi...
https://pubmed.ncbi.nlm.nih.gov/10642715Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation".
R S Mitchell, D C Miller, M D Dake...
https://pubmed.ncbi.nlm.nih.gov/10391350