Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Launched by GUSTAVO ODERICH · Sep 4, 2013

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat certain types of large blood vessel bulges called aortic aneurysms, specifically those located near the kidneys or in the chest. The treatment involves using a special device called a custom-made Cook Zenith® Fenestrated AAA Endovascular Graft, which is inserted through blood vessels to repair the aneurysm without the need for major surgery. The researchers want to see how well this method works and whether it improves patients' quality of life.

To participate in the study, patients should be between the ages of 65 and 74 and have a specific kind of aortic aneurysm that is at least 5 centimeters wide or has been growing quickly. Those with certain health issues or who cannot follow the study’s requirements may not be eligible. If someone joins the trial, they can expect regular check-ups to monitor their progress and health after the procedure. This trial is currently recruiting participants, and it aims to provide valuable insights into improving treatment for these serious conditions.

Gender

ALL

Eligibility criteria

• • General Inclusion Criteria
• * A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
• • Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
• • Aneurysm with a history of growth ≥ 0.5 cm per year
• • Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
• • General Exclusion Criteria
• • Less than 18 years of age
• • Unwilling to comply with the follow-up schedule
• • Inability or refusal to give informed consent by the patient or a legally authorized representative
• • Pregnant or breastfeeding
• • Life expectancy \< 2-years
• • Additional medical restrictions as specified in the Clinical Investigation Plan
• • Additional anatomical restrictions as specified in the Clinical Investigation Plan