Clinical trial NCT00483249: Endovascular Exclusion of Thoracoabdominal And/or Paravisceral Abdominal Aortic Aneurysm
Official title: Endovascular Exclusion of Thoracoabdominal And/or Paravisceral Abdominal Aortic Aneurysm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysm
Paravisceral Abdominal Aortic Aneurysm
Keywords: Thoracoabdominal
Paravisceral
Aneurysm
Endovascular
Stent-Graft
Aorta
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-06-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful implantation of TAAA branched stent-graft.
timeFrame: 1 month
Secondary outcomes:
measure: Long term success of TAAA branched stent-graft treatment.
timeFrame: 5 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Division of Vascular Surgery, SFVAMC
state: California
city: San Francisco
country: United States
facility: Division of Vascular Surgery, UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Warren J Gasper, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Werlin EC, Kaushik S, Gasper WJ, Hoffman M, Reilly LM, Chuter TA, Hiramoto JS. Multibranched endovascular aortic aneurysm repair in patients with and without chronic aortic dissections. J Vasc Surg. 2019 Nov;70(5):1419-1426. doi: 10.1016/j.jvs.2019.02.048. Epub 2019 Jul 18.
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