Endovascular Exclusion of Thoracoabdominal And/or Paravisceral Abdominal Aortic Aneurysm

Launched by WARREN J. GASPER, MD · Jun 5, 2007

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat certain types of aortic aneurysms, specifically thoracoabdominal and paravisceral abdominal aortic aneurysms. An aortic aneurysm is a bulge in the aorta, the large blood vessel that carries blood from the heart to the rest of the body. The trial is testing a procedure that involves placing a special device called a stent-graft over the aneurysm to help prevent it from growing or bursting. Researchers want to find out how safe and effective this treatment is compared to traditional surgery.

To be eligible for this study, participants should be adults aged 65 to 74 with larger aneurysms—at least 6 cm for men and 5.5 cm for women—or those whose aneurysms are growing quickly. It’s also important that participants have a life expectancy of more than two years and can give their consent to take part in the study. Participants can expect to follow a specific schedule for check-ups after the procedure to monitor their health. It’s worth noting that people who are pregnant, have a severe infection, or have certain allergies won't be able to join the study. This trial aims to provide more options for patients with these serious conditions.

Gender

ALL

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.