Evaluation of a new endovascular graft for treating aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 for patients with aortic aneurysms affecting major visceral arteries. The study focuses on patients with thoracoabdominal, pararenal, or juxtarenal aortic aneurysms that meet specific size and growth criteria. Participants will be monitored for outcomes related to the treatment's efficacy and safety.

Why it matters

Who can join: the full rules

Include Criteria:

1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator

Exclusion Criteria:

1. Age \< 18 years
2. Life expectancy \< 2 years
3. Pregnant, breast-feeding, or planning to become pregnant within 60 months
4. Inability or refusal to give informed consent by the patient or legally authorized representative
5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Where it's running

• University of Alabama Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• UC San Diego
  La Jolla, California, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Stanford Hospitals and Clinics
  Stanford, California, United States Recruiting
• Medstar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• University of Florida Shands Hospital
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Gustavo Oderich, MD — Baylor College of Medicine
• Study coordinator: Chanda Bell, RN, BSN
• Email: chanda.bell@cookmedical.com
• Phone: 765-463-7537

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Outcomes after physician-modified fenestrated and branched stent grafts for complex aortic aneurysms

  This study will test whether physician-modified fenestrated and branched stent grafts are safe and effective for people with juxtarenal, pararenal, or thoracoabdominal aortic aneurysms who are high risk for open surgery.

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• Using AI to measure aortic size from CT scans

  This project will test whether an AI tool called Aorta AIM can automatically measure the aorta on CT scans for adults who have or are being checked for aortic aneurysms.

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• iHub Stent-Graft for Iliac Aneurysms: Safety and Performance in Endovascular Repair

  This trial tests the iHub stent-graft to see if it is safe and works well to repair iliac artery aneurysms in adults needing endovascular treatment.

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• Comparing pain relief methods for patients undergoing vascular surgery

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• Comparing quality of life after different types of aortic aneurysm repair

  This study looks at how different types of surgery for abdominal aortic aneurysms affect the quality of life for patients over three years.

  Recruiting Karolinska University Hospital · Stockholm · NCT05774938

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.