Clinical trial NCT01524211: Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Official title: Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracoabdominal Aortic Aneurysm
Aortic Arch Aneurysm
Keywords: Aortic Aneurysms
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: William Cook Australia
name: Bolton Medical
First posted: 2012-02-01
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Zenith t-Branch Subject Cohort: All eligible subjects will receive treatment with the investigational t-Branch Endovascular Graft. (Total 225 subjects)

Terumo Arch Branch Cohort: All eligible subjects will receive treatment with the investigational Terumo Arch Branch Endovascular Graft. (Total 10 Subjects)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Early Mortality & Stroke
timeFrame: 30 days post implant of the branch endografts
Secondary outcomes:
measure: Rates of Neurologic Complications/Late Branch Vessel Patency
timeFrame: Day 0-Day 30 (Early) Day 31-1825 (Late)
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
state: Florida
Study officials:
affiliation: Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
name: W. Anthony Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: