Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Treatment success
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Treatment success
Time Frame: 12 months
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.
Number of patients with major adverse events
Time Frame: 30 days
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.
Secondary Outcomes
- Change in Quality of Life(Baseline, 30 days, 6 months, and annually at 1, 2, 3, 4 and 5 years)
Investigators
Bernardo Mendes, MD
Principal Investigator
University of California, Los Angeles