Aortic Arch Aneurysm, Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
Aortic Aneurysms
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.
Interventions
DEVICETerumo Arch Branch
The Arch Branch endograft is a custom-made endograft based on the Relay thoracic stent graft platform. The device is intended to land proximally in the ascending aorta just distal to the sinotubular junction, and distally either in the native thoracic aorta for focal arch pathologies, or more extensive pathologies either extended with another commercially available thoracic endograft or mated to a pre-existing thoracic endograft, which would serve as a distal landing zone. It is constructed of polyester graft material (same as those used for the Terumo Relay Plus or Pro) sewn to self-expanding nitinol stents with suture. The graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, the stents provide the necessary attachment and seal of the graft to the aortic wall.
DEVICEZenith® t-Branch
The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.
Sponsors
Baptist Health South Florida
William Cook Australia
Bolton Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Mortality & Stroke | 30 days post implant of the branch endografts | The primary aim of this study is to determine the rate of early mortality and stroke after branch endograft treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Neurologic Complications/Late Branch Vessel Patency | Day 0-Day 30 (Early) Day 31-1825 (Late) | The secondary aims of this study are to determine the rates of neurologic complications and late branch/target vessel patency, type I and III endoleaks and secondary interventions after branch endograft treatment. In those subjects enrolled in the t-Branch cohort we will evaluate the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms. |
Countries
United States
Contacts
CONTACTLisamarie Kernicky, RN;BSN;CCRC
PRINCIPAL_INVESTIGATORW. Anthony Lee, MD
Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
Outcome results
None listed