Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Study Update as of 3/31/2025; 186 subjects successfully have been implanted with the Zenith t-Branch Device and 1 subject has been implanted with the Arch Branch to date and recruitment is ongoing.

Zenith t-Branch Eligibility Criteria:

Inclusion criteria

The patient must have one of the following:

• 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
• Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
• Penetrating ulcers: ≥20mm in depth or
• Chronic type B aortic dissections: ≥50mm total aortic diameter or
• 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

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

Medical Criteria

• Uncontrolled systemic infection
• Untreatable malignancy
• Uncontrollable anaphylaxis to iodinated contrast
• Known allergy(ies) to device materials

Anatomic Criteria

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

• 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
• Penetrating ulcers: ≥20 mm in depth, or
• 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.

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

Exclusion criteria

General Criteria

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

Medical Criteria

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

Anatomic Criteria

• Any pathology of mycotic origin.
• Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).
• Acute (<2 weeks) aortic dissection.
• Type A dissection.
• Symptomatic or ruptured pathology.
• Anatomy suitable for repair using commercially-available endograft.
• Inability to insert the Arch Branch endograft through an iliofemoral approach.
• Untreated, known extracranial carotid stenosis >80%.
• Ascending aortic angulation with radius of curvature <15mm in the intended landing zone.
• Proximal aortic landing zone length <25 mm.
• Proximal aortic landing zone diameter of >43mm or <28 mm.
• Distal aortic landing zone diameter <20 mm.
• Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk <70mm.
• Target arch vessels:
• 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.