Modified endograft treatment for complex aortic aneurysms

A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair

This study is testing a special type of stent to see if it can safely treat complex aortic aneurysms in high-risk patients who can’t use regular devices.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Davis (other)
• Drugs / interventions: radiation
• Locations: 1 site (San Diego, California)
• Trial ID: NCT05339061 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the use of a physician modified endograft for patients with complex aortic aneurysms that involve critical arteries such as the renal arteries and celiac trunk. The study aims to provide a minimally invasive treatment option for high-risk patients who cannot be treated with standard endovascular devices. A total of 40 subjects will be enrolled at a single site, with follow-up assessments conducted over five years to monitor safety and effectiveness. The primary endpoints include freedom from major adverse events and treatment success at one year post-procedure.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with complex aortic aneurysms that are not amenable to standard endovascular repair.

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

Why it matters

Potential benefit: If successful, this approach could offer a safer and more effective treatment option for patients with complex aortic aneurysms.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating complex aortic conditions with modified endografts.

Eligibility criteria

---Inclusion criteria---

1. Patient is \> 18 years of age
2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
3. Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
4. Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:

   * Aortic aneurysm with diameter ≥ 5.5cm
   * Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months
   * Symptomatic aortic aneurysm
5. Cannot be treated with a currently available non-modified approved device
6. High risk for open surgical repair based on any of the factors below:

   1. 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
   2. 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
7. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit
8. Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm
9. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.
10. The resultant repair should preserve patency in at least one hypogastric artery.
11. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm
12. Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.

---Exclusion Criteria---

-General Exclusion Criteria-

1. Patient has a mycotic aneurysm
2. Patient has a ruptured aneurysm requiring urgent or emergent repair
3. Patient has a systemic or local infection that may increase the risk of graft infection
4. Patient has a body habitus that would inhibit X-ray visualization of the aorta.
5. Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution
6. Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair.
7. Patient is currently participating in another investigational device or drug clinical trial.

-Medical Exclusion Criteria-

1. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
2. Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.
3. Patient has uncorrectable coagulopathy
4. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
5. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
6. Patient has active malignancy with life expectancy of less than 2 years
7. Patient has a limited life expectancy of less than 2 years.
8. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

-Anatomic Exclusion Criteria-

1. Significant occlusive disease, tortuosity or calcification that would prevent endovascular access
2. Proximal seal site with a circumferential thrombus/atheroma
3. Inability to maintain at least one patent hypogastric artery
4. Shaggy aorta
5. Patient is not amenable to a temporary or permanent open surgical or endovascular conduit

Where this trial is running

San Diego, California

• University of California San Diego — San Diego, California, United States (RECRUITING)

Study contacts

• Study coordinator: Sina Zarrintan, MD

Conditions: Complex Abdominal Aortic Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm