Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Baptist Health South Florida

Status: Enrolling

Conditions: Aortic Arch Aneurysm; Thoracoabdominal Aortic Aneurysm

Treatments: Device: Terumo Arch Branch; Device: Zenith® t-Branch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01524211

IDE G110081

Details and patient eligibility

About

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.

Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.

Full description

Study Update as of 5/31/2024; 179 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing. Arch Branch Subject Cohort enrollment is open.

Enrollment: 235 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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235 participants in 2 patient groups

Single Treatment Arm-Zenith t-Branch Cohort

Experimental group

Description:

Zenith t-Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.

Treatment:

Device: Zenith® t-Branch

Single Treatment Arm-Terumo Arch Branch Cohort

Experimental group

Description:

Terumo Arch Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Terumo Arch Branch Endovascular Graft.

Treatment:

Device: Terumo Arch Branch