Repair of complex aortic aneurysms using custom devices

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

This study is testing custom-made devices to see if they can safely and effectively treat complex aortic aneurysms in patients who can't use standard options, especially those at high risk or with conditions like Marfan syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Massachusetts, Worcester (Academic / other)
• Locations: 1 site (Worcester, Massachusetts)
• Trial ID: NCT02050113 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of custom-made devices and modified FDA-approved endovascular grafts for treating complex aortic aneurysms in patients whose anatomy is unsuitable for standard devices. It focuses on individuals at high risk for open surgical repair and those with connective tissue diseases like Marfan syndrome. The study involves determining the appropriate type of endograft based on patient anatomy and urgency of repair, with a third-party reviewer confirming the treatment decision. The aim is to provide a timely and effective solution for patients with critical vascular conditions.

Who should consider this trial

Good fit: Ideal candidates include adults with complex aortic aneurysms who cannot be treated with standard devices and are at high risk for open surgery.

Not a fit: Patients with aortic aneurysms that can be treated with currently available non-modified devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment options and outcomes for patients with complex aortic aneurysms.

How similar studies have performed: Other studies have shown promise in using modified and custom devices for complex aortic aneurysms, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* A patient may be suitable for inclusion in the study if the patient has at least one of the following:

  1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
  2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms

     General Inclusion Criteria

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  1. Cannot be treated with a currently available non-modified approved device
  2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
  3. At least 18 years of age
  4. Not pregnant or breastfeeding
  5. Willing and able to comply with five years of follow-up
  6. Willing and able to provide informed consent prior to enrollment
  7. No systemic or local infection that may increase the risk of endovascular graft infection
  8. High risk for open surgical repair based on any of the factors below:

     a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD

     Exclusion Criteria:
* Exclusion Criteria Medical Exclusion Criteria

  1. Cultural objection to receipt of blood or blood products
  2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
  3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated
  4. Uncorrectable coagulopathy
  5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
  6. Patient has active malignancy with life expectancy of less than 2 years
  7. Patient has life expectancy less than two years

Anatomical Exclusion Criteria

1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
2. Proximal neck length ≤25 mm
3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)

   1. For use of Zenith Flex: diameter \>32 mm or \<18 mm
   2. For use of Zenith TX2: diameter \>38 mm or \<24 mm (for proximal and distal neck diameter)
4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
5. Proximal neck diameter change over the length of the proximal seal zone \>4 mm
6. Proximal seal site with a circumferential thrombus/atheroma
7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \<7.0 mm at any point along access length (prior to deployment)
8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \>21 mm at distal fixation site
9. Iliac artery distal fixation site \<10 mm in length
10. Non-bifurcated segment of any artery to be stented \< 15 mm in length
11. Artery to be stented with a maximum diameter \<3 mm or \>10 mm at the vessel ostium
12. Inability to maintain at least one patent hypogastric artery

Where this trial is running

Worcester, Massachusetts

• UMass Memorial Health Care - University Campus — Worcester, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Andres Schanzer, MD — University of Massachusetts, Worcester
• Study coordinator: Shauneen Valliere, MSN, NP

Conditions Complex Aortic Aneurysms; Thoracoabdominal Aneurysms; Pararenal Aneurysms; Juxtarenal Aneurysms; Marfan Syndrome; Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome; Aortic Arch Aneurysm