Evaluating new endografts for treating aortic aneurysms

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

This study is testing two new types of stent-grafts to see if they can safely and effectively treat aortic aneurysms in patients who can't use standard treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baptist Health South Florida (other)
• Locations: 1 site (Boca Raton, Florida)
• Trial ID: NCT01524211 on ClinicalTrials.gov

What this trial studies

This study aims to gather data on the effectiveness of the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for treating thoracoabdominal and aortic arch aneurysms. It includes two cohorts: one focusing on the Zenith t-Branch device and another on the Terumo Arch Branch endograft for patients with proximal thoracic aortic pathologies unsuitable for conventional treatments. The study is currently ongoing, with 179 subjects already implanted with the Zenith t-Branch device. Recruitment for the Arch Branch cohort is also open.

Who should consider this trial

Good fit: Ideal candidates include patients with specific types of thoracoabdominal or aortic arch aneurysms that meet the study's inclusion criteria.

Not a fit: Patients with a life expectancy of less than 12 months or those who refuse blood products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with complex aortic aneurysms, potentially improving outcomes and reducing complications.

How similar studies have performed: Other studies have shown promise with similar endovascular approaches, indicating potential for success in this area.

Eligibility criteria

Zenith t-Branch Eligibility Criteria:

Inclusion Criteria

The patient must have one of the following:

1. Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or
2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
3. Penetrating ulcers: ≥20mm in depth or
4. Chronic type B aortic dissections: ≥50mm total aortic diameter or
5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.

Additional criteria for LP material

• Iliofemoral access vessels \<8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator

Exclusion Criteria

General Criteria

1. Life-expectancy less than 12 months
2. Refusal to receive blood products
3. Age \<18 years
4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
5. Unwilling to comply with the follow-up schedule
6. Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized

Medical Criteria

1. Uncontrolled systemic infection
2. Untreatable malignancy
3. Uncontrollable anaphylaxis to iodinated contrast
4. Known allergy(ies) to device materials

Anatomic Criteria

1. Any pathology of mycotic origin
2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
3. Inability to insert the Zenith® t-Branch device through iliofemoral approach
4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
5. Proximal landing zone length \<25mm to allow secure fixation and seal
6. Proximal landing zone diameter of \<24mm or \>42mm
7. Distal landing zone length \<25mm in the abdominal aorta or \<20mm in the iliac arteries
8. Distal landing zone diameter of \<14mm or \>30mm in the abdominal aorta, or \<7mm or \>28mm in the iliac arteries

Terumo Arch Branch Eligibility Criteria

Inclusion Criteria

The subject must have one of the following:

1. Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or \> 50 mm with a history of growth ≥5 mm in the last 6 months, or
2. Penetrating ulcers: ≥20 mm in depth, or
3. Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.

   1. Age \>85 years old.
   2. Prior median sternotomy (for any reason).
   3. Prior open or endovascular thoracic aortic repair.
   4. Severe aortic calcification.
   5. Severe occlusive disease of one or more arch vessels.
   6. Moderate-severe COPD (FEV1 \<80% predicted).
   7. Severe CKD (Stage 3 or greater, eGFR \<60 mL/min).
   8. LV dysfunction.
   9. Chronic steroid or immunosuppressive use.
   10. History of increased risk of bleeding.
   11. Neurocognitive deficits that may significantly impact postoperative rehabilitation.
   12. Musculoskeletal conditions that may significantly impact postoperative rehabilitation.

Exclusion Criteria

General Criteria

1. Life expectancy \<1 year.
2. Refusal to receive blood products.
3. Age \<18 years.
4. Pregnant, breastfeeding, or planning to become pregnant within 60 months.
5. Unwilling to comply with the follow-up schedule.
6. Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized.
7. Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution.

Medical Criteria

1. Pending cardiac surgery.
2. Untreatable severe, symptomatic coronary or valvular disease.
3. Prior mechanical aortic valve replacement (not bioprosthetic).
4. History of TAVR (Transcatheter Aortic Valve Replacement)
5. Severe, calcific aortic valvular stenosis.
6. Uncontrolled systemic infection.
7. Untreatable malignancy with \<1 year expected survival.
8. Uncontrollable anaphylaxis to iodinated contrast.
9. Known allergy(ies) to device materials. (i.e. polyester, nitinol).

Anatomic Criteria

1. Any pathology of mycotic origin.
2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).
3. Acute (\<2 weeks) aortic dissection.
4. Type A dissection.
5. Symptomatic or ruptured pathology.
6. Anatomy suitable for repair using commercially-available endograft.
7. Inability to insert the Arch Branch endograft through an iliofemoral approach.
8. Untreated, known extracranial carotid stenosis \>80%.
9. Ascending aortic angulation with radius of curvature \<15mm in the intended landing zone.
10. Proximal aortic landing zone length \<25 mm.
11. Proximal aortic landing zone diameter of \>43mm or \<28 mm.
12. Distal aortic landing zone diameter \<20 mm.
13. Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk \<70mm.
14. Target arch vessels:
15. Distal branch landing zone dimensions: I. Brachiocephalic trunk (innominate artery, BCT): Diameter \>24 mm or \<6 mm, length \<15 mm. ii. Common carotid artery: Diameter \<6 mm, length \<25mm. iii. Subclavian artery: Diameter \<6 mm, length \<25mm.

Where this trial is running

Boca Raton, Florida

• Baptist Health South Florida|Boca Raton Regional Hospital (BRRH) — Boca Raton, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: W. Anthony Lee, MD — Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
• Study coordinator: Lisamarie Kernicky, RN;BSN;CCRC

Conditions: Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Aortic Aneurysms