Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm · Paravisceral Abdominal Aortic Aneurysm
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 250 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria
1. 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.
2. Anticipated mortality comparable to published rates with conventional surgical treatment.
3. Life expectancy more than 2 years.
4. Ability to give informed consent.
5. Willingness to comply with follow-up schedule.
6. Suitable arterial anatomy for endovascular repair.
Exclusion Criteria
1. Free rupture of the aneurysm.
2. Pregnancy.
3. Known allergy to Nitinol, stainless steel, or polyester.
4. Unwillingness or inability to comply with the follow up schedule.
5. Serious systemic or groin infection.
6. Uncorrectable coagulopathy.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Interventional
Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).
Device: Endovascular Branched Stent-Graft
Endovascular Branched Stent-Graft DEVICE
Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Successful implantation of TAAA branched stent-graft.
Time frame: 1 month
Not reported in this registry record.
Secondary measures
Long term success of TAAA branched stent-graft treatment.
Time frame: 5 years
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
Division of Vascular Surgery, SFVAMCSan Francisco, California, United StatesRecruiting
Division of Vascular Surgery, UCSFSan Francisco, California, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Warren J. Gasper, MD
- Study start
- 2005-05
- Primary completion
- 2028-12 Estimated
- Study completion
- 2028-12 Estimated
- First posted
- Jun 6, 2007 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026