Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts

NCT06526676 | Recruiting DMC FDA Device

• 1 other identifier: 25-1031
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches.

Conditions

Juxtarenal Aortic Aneurysm; Pararenal Aneurysm; Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Number of patients with major adverse events

  Total number of patients to experience a major adverse event as defined as any cause mortality, bowel ischemia (requiring surgical therapy), type I myocardial infarction (rise of troponin levels at least 1 value above 99th percentile of upper limit and with at least one of the following: symptoms of acute myocardial ischemia, new ischemic ECG changes, development of new pathological Q waves, imaging evidence of loss of viable myocardium or new regional wall motion abnormalities, or identification of coronary thrombus by angiography or by autopsy), paraplegia (Level 3), renal failure (need for renal replacement therapy or \> 50% decline in eGFR), respiratory failure (respiratory failure requiring ventilatory support \> 24 hours or re-intubation), major stroke.

  30 days

• Treatment success

  Total number of patients to achieve treatment success as defined by: technical success, defined as successful delivery, deployment and withdrawal of the physician-modified endovascular graft with preservation and patency of those branch vessels intended to be preserved; freedom from aneurysm enlargement \>5 mm; freedom from secondary interventions for type I or type III endoleak, stent-graft migration, device integrity failure (e. g., fracture), and patency-related events; and freedom from aneurysm rupture or conversion to open repair.

  12 months

Secondary Outcomes (1)

• Change in Quality of Life

  Baseline, 30 days, 6 months, and annually at 1, 2, 3, 4 and 5 years

Study Arms (3)

Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA

EXPERIMENTAL

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft

Subjects with thoracoabdominal aortic aneurysms

EXPERIMENTAL

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft

Subjects with urgent or emergent aneurysms

EXPERIMENTAL

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft

Interventions

Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft DEVICE

Physician-modified stent grafts that utilizes multiple stent grafts with a combination of fenestrations and/or branches

Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA; Subjects with thoracoabdominal aortic aneurysms; Subjects with urgent or emergent aneurysms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient may be included in the study if at least one of the following is present and is considered appropriate for treatment with a physician modified stent graft. Patients must be deemed high risk for traditional open surgical repair, if any of the following conditions are present.
• Patients will be deemed physiologically high risk if any of the following conditions are present:
• Older than 75 years of age
• Chronic obstructive pulmonary disease
• Congestive heart failure
• Previous myocardial infarction, coronary stent, or bypass
• Chronic renal insufficiency with baseline eGFR \< 40 ml/min
• American Society of Anesthesiologist (ASA) score \> 3
• Patient will be deemed anatomically high risk if any of the following conditions are present:
• Prior intraabdominal operation(s)
• Prior abdominal wall reconstructions. (ie. Ventral hernia repairs)
• Prior radiation therapy targeting abdomen and/or pelvis
• History of intraabdominal sepsis. (ie. Diverticulitis managed with percutaneous drainage)
• Arm 1 (Short neck infrarenal, juxtarenal, suprarenal and extent IV TAA)
• Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.

You may not qualify if:

• Patients must be excluded from the study if any of the following conditions are true:
• Less than 18 years of age
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent by the patient or a legally authorized representative
• Pregnant or breastfeeding
• Life expectancy \< 2-years
• Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.
• Patients eligible for treatment with any FDA-approved marketed device within its instructions for use
• Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufactured-made device at another institution
• Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated procedure (\>30 days). Examples include remote (\>30 days) participation in a thoracic, abdominal, or iliac branch device trial, or participation in a percutaneous aortic valve trial. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.
• Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane, or gold.
• History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated.
• Uncorrectable coagulopathy.
• Mycotic aneurysm or patients with evidence of active systemic infection.
• History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfan's syndrome), except for those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular Ehlers Danlos).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Bernardo C Mendes, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate M Horiuchi, MPH

CONTACT

(310) 267-1039; khoriuchi@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 30, 2024
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2032
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)