Thoracoabdominal Aortic AneurysmNCT01524211
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
A study testing Zenith® t-Branch and Terumo Arch Branch in people with Thoracoabdominal Aortic Aneurysm and Aortic Arch Aneurysm, run by Baptist Health South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm
- What is being tested?
- Zenith® t-Branch and Terumo Arch Branch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2012to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- 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.
Who cannot join
- 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
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- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
Boca Raton, Florida, 33486
Lisamarie Kernicky, RN;BSN;CCRC, 561-955-5239, lkernicky@brrh.com
About this study
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.
Read the 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.
- Being tested
- Zenith® t-Branch, Terumo Arch Branch
- Keywords
- Aortic Aneurysms
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Aneurysm, Aortic Arch, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® t-BranchDevice
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.
Terumo Arch BranchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Treatment Arm-Zenith t-Branch Cohort | Experimental | Zenith t-Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft. Receives: Device: Zenith® t-Branch |
| Single Treatment Arm-Terumo Arch Branch Cohort | Experimental | Terumo Arch Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Terumo Arch Branch Endovascular Graft. Receives: Device: Terumo Arch Branch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Mortality & Stroke
The primary aim of this study is to determine the rate of early mortality and stroke after branch endograft treatment.
Measured: 30 days post implant of the branch endografts
Secondary outcomes (1)
Rates of Neurologic Complications/Late Branch Vessel Patency
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.
Measured: Day 0-Day 30 (Early) Day 31-1825 (Late)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study start25 Jan 2012
- Primary completionDec 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- William Cook Australia, Bolton Medical
- Responsible party
- Sponsor
- Investigators
- W. Anthony Lee, MD, Principal investigator, Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524211
- Sponsor's protocol ID
- IDE G110081
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2012
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16.
PubMed 37330702
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT01524211
- Acronym / sponsor ID
- IDE G110081
- Keywords
- Aortic Aneurysms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- William Cook Australia, Bolton Medical
- Study start
- 25 Jan 2012 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Single Treatment Arm-Zenith t-Branch Cohort | Experimental | Device: Zenith® t-BranchZenith t-Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft. |
| Single Treatment Arm-Terumo Arch Branch Cohort | Experimental | Device: Terumo Arch BranchTerumo Arch Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Terumo Arch Branch Endovascular Graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (56 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenith® t-BranchThe 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. | Device | Single Treatment Arm-Zenith t-Branch Cohort |
| Terumo Arch BranchThe 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. | Device | Single Treatment Arm-Terumo Arch Branch Cohort |
Primary outcome
Early Mortality & Stroke
Time frame: 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.
1 secondary outcome
Rates of Neurologic Complications/Late Branch Vessel Patency
Time frame: Day 0-Day 30 (Early) Day 31-1825 (Late)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 37330702Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
W. Anthony Lee, MD principal investigator
Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenith® t-Branch and Terumo Arch Branch in people with Thoracoabdominal Aortic Aneurysm and Aortic Arch Aneurysm, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 56 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisamarie Kernicky, RN;BSN;CCRC (561-955-5239, lkernicky@brrh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Mortality & Stroke (time frame: 30 days post implant of the branch endografts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.