Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

Launched by BOLTON MEDICAL · Dec 9, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a medical device called the Treovance Stent-Graft, which is used to treat a condition known as an abdominal aortic aneurysm (AAA). An AAA is a bulge in the main blood vessel that carries blood from the heart to the rest of the body, and if it grows too large, it can be dangerous. The goal of this trial is to find out if the Treovance Stent-Graft is safe and effective for patients with this condition.

To be eligible for this trial, participants need to have been diagnosed with an AAA that is larger than 4.5 cm for men or 4.0 cm for women, or has recently increased in size. However, those who have a tear in the aorta, a ruptured aneurysm, or have already had surgery for an AAA are not eligible. The trial is currently active but not recruiting new participants. If someone qualifies, they will work closely with their healthcare team throughout the study to monitor their health and the performance of the stent-graft. This trial is important as it could lead to better treatment options for people with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
• • Subject must have an infrarenal AAA that is \> 4.5 cm in diameter for males, or \> 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
• Exclusion Criteria:
• • Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
• • Subject has had a prior AAA repair (endovascular or surgical)
• • Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure