Physician-modified fenestrated and branched aortic endograft repair for thoracoabdominal aneurysms

Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)

This trial tests a physician-modified fenestrated and branched endograft to repair thoracoabdominal aortic aneurysms in adults who are high-risk for open surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 50 Years to 95 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 2 sites (New Haven, Connecticut and 1 other locations)
• Trial ID: NCT02989948 on ClinicalTrials.gov

What this trial studies

This is a prospective, two-arm feasibility trial using a physician-modified Cook Zenith Alpha thoracic endovascular graft in adults with thoracoabdominal aortic aneurysms that meet standard size criteria for repair. Eligible patients are those judged high-risk for open surgical replacement and who are not candidates for commercially approved endovascular devices. Participants undergo endovascular implantation of the modified fenestrated and branched graft and will be followed for five years with systematic recording of major adverse events. Outcomes will be compared to previously published open-repair results and monitored by local oversight and regulatory authorities.

Who should consider this trial

Good fit: Adults aged 50 or older with thoracoabdominal aortic aneurysms meeting size thresholds who are considered high-risk for open repair and ineligible for approved endovascular devices.

Not a fit: Patients who are good candidates for standard open repair, who meet Instructions for Use of approved endovascular grafts, or who have aneurysms from excluded causes may not benefit from this approach.

Why it matters

Potential benefit: If successful, the approach could offer a less invasive repair that lowers perioperative risk and shortens recovery compared with open surgical replacement.

How similar studies have performed: Single-center series and registry reports of physician-modified fenestrated/branched endografts have shown promising short- and mid-term outcomes, but large multicenter or randomized evidence is limited.

Eligibility criteria

MAIN ARM - Inclusion Criteria:

1. Must be a man or woman 50 years of age or older by the date of informed consent.
2. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
3. Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).
4. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
6. Must be able to provide informed consent.
7. Must be able to comply with the five year study assessment schedule of events.
8. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.

MAIN ARM - Exclusion Criteria:

1. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
2. Ruptured or acutely symptomatic aortic aneurysm.
3. Known connective tissue disorder.
4. Imaging demonstrating any of the following:

   * Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).
   * Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).
   * Branch vessel target (renal, superior mesenteric, or celiac) \< 5 mm or \> 10 mm in average diameter.
   * Untreated left subclavian artery stenosis or occlusion.
   * Untreated unilateral or bilateral hypogastric artery occlusion.
   * Signs that the inferior mesenteric artery is indispensable.
   * Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.
5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.
6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
7. Have uncorrectable coagulopathy.
8. Have unstable angina.
9. Have a body habitus that would inhibit X-ray visualization of the aorta.
10. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
11. Known to be participating in any other clinical study which may affect performance of this device.
12. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
13. Contraindication to oral antiplatelet therapy.
14. Prisoners or those on alternative sentencing.
15. Known systemic infection with potential for endovascular graft infection.
16. Anticipated need for MRI scanning within 3 months of insertion of investigational product.
17. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient.

EXPANDED ACCESS ARM - Inclusion Criteria

1. Must be a man or woman 50 years of age or older by the date of informed consent
2. Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and/or distal seal.
3. Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture
4. Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair
5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
6. Patient must be able to provide informed consent
7. Must be able to comply with the five year study assessment schedule of events
8. Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years

EXPANDED ACCESS ARM - Exclusion Criteria

1. Known or suspected mycotic aneurysm
2. Ruptured aneurysm with hemodynamic instability
3. Known connective tissue disorder
4. Imaging demonstrating any of the following:

   * Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)
   * Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)
   * Branch vessel target (renal, superior mesenteric, or celiac) \> 10 mm in average diameter
5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
7. Have uncorrectable coagulopathy
8. Have a body habitus that would inhibit X-ray visualization of the aorta
9. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
10. Known to be participating in any other clinical study which may affect performance of this device
11. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
12. Contraindication to oral antiplatelet therapy
13. Prisoners or those on alternative sentencing
14. Known systemic infection with potential for endovascular graft infection
15. Anticipated need for MRI scanning within 3 months of insertion of investigational product
16. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient

Where this trial is running

New Haven, Connecticut and 1 other locations

• Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Active_not_recruiting)

Study contacts

• Principal investigator: David P. Kuwayama, M.D., M.P.A. — Yale University
• Study coordinator: David P. Kuwayama, M.D., MPA

Conditions Aortic Aneurysm, Thoracoabdominal; endovascular; physician-modified; graft; fenestration