Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms

Launched by VASCUTEK LTD. · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment for abdominal aortic aneurysms (AAA) using a device called the TREO® modular aortic endograft. An abdominal aortic aneurysm is a bulge in the main blood vessel that carries blood from the heart to the rest of the body, and it can be dangerous if it gets too large or ruptures. The trial will involve collecting health information from patients who receive this device over a period of five years to see how well it works and to monitor for any serious complications, such as heart attacks or strokes.

To be eligible for the trial, participants must be at least 45 years old and have certain characteristics related to their aneurysm, such as a size above a specific measurement or symptoms like abdominal pain. They also need to have the right anatomy for the device to be implanted safely. Those interested in participating will need to commit to follow-up visits for the duration of the study. The trial is currently not recruiting participants, but it aims to gather important information on the safety and effectiveness of this new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient who has confirmed his/her non-opposition to the use of his/her data in the study.
• • 2. Patient aged 45 years or older.
• 3. Patient with AAA with one of the following criteria:
• • Maximum diameter ≥50 mm for women and ≥55 mm for men
• • Rapid growth (≥5 mm in 6 months or ≥10 mm in 12 months)
• • Unruptured AAA with clinical symptoms of abdominal pain
• 4. Adequate anatomy for TREO® stent graft implantation, including:
• • Adequate iliac and femoral arteries for the modular system
• • Suprarenal angle less than 45 degrees
• • Infrarenal aortic neck greater than or equal to 10 mm in length with an angle less than 60° and an internal diameter of 17mm-32mm, or an infrarenal aortic neck greater than or equal to 15 mm in length with an angle between 60 and 75° and an internal diameter of 16mm-30mm
• • Distal iliac sealing distance ≥ 10 mm and an iliac diameter between 8-13 mm or a distal iliac sealing distance ≥ 15 mm and a diameter between 13-21 mm
• • 5. Ability to follow the entire protocol from 1 to 60 months
• • 6. Life expectancy greater than 2 years
• Exclusion Criteria:
• • 1. Patients refusing treatment and follow-up as part of the study
• • 2. Infected or ruptured aneurysm
• • 3. Associated aortic lesion (thoracic or thoracoabdominal aneurysm) requiring management
• • 4. Renal failure defined by creatinine \> 2.5 mg/dL or patient in pre-dialysis status and impossibility of intervention with use of CO2 injection
• • 5. New York Heart Association (NYHA) class IV
• • 6. Aneurysmal, dissected distal implantation zone, or including calcifications and/or significant thrombus that could compromise sealing
• • 7. Tortuous iliac and/or femoral access and/or including calcified stenosis
• • 8. Systemic infection that could increase the risk of infection of the endoprosthesis
• • 9. Pathology of the supporting tissues such as collagenosis (Marfan or Ehler-Danlos, etc.)
• • 10. Known drug use
• • 11. Known sensitivity or allergy to the materials to be implanted
• • 12. Patients contraindicated for antiplatelet treatment
• • 13. Patients with an uncontrolled hematological disorder or heparin-induced thrombocytopenia
• • 14. Patients who are pregnant or planning to become pregnant
• • 15. Patients considered hemodynamically unstable or requiring emergency treatment
• • 16. Patients with severe arterial disease leading to a negative "outflow" that may degrade the permeability of implanted stents
• • 17. Scheduled hybrid aortic technique (surgical and endovascular)
• • 18. Patients with complex iliac access outside the manufacturer's indications and recommendations that may lead to procedural failure