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New treatment option for Juxtarenal Aortic Aneurysm
Official title Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts
ClinicalTrials.gov ID: NCT06526676
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Older than 75 years of age
- Chronic obstructive pulmonary disease
- Congestive heart failure
- Previous myocardial infarction, coronary stent, or bypass
You likely can't join 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
See the full eligibility criteria
Who can join
- 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...
- 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) Patients will then be included in one of three arms with the specified as follows:
- 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.
- Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aneurysm with a history of growth ≥ 0.5 cm in one year.
- Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
- Presence of juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with...
- Arm 2 (Thoracoabdominal aortic aneurysms)
- Extent I, II, or III thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
- Extent I, II, or III thoracoabdominal aortic aneurysm with a history of growth ≥ 0.5 cm in one year.
- Extent I, II, or III thoracoabdominal saccular aortic aneurysms deemed at significant risk for rupture based upon physician interpretation.
- Presence of Extent I, II, or III thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular...
- Arm 3 (Urgent or emergent aneurysms) o Ruptured, contained ruptured or symptomatic juxtarenal, pararenal, suprarenal or thoracoabdominal aortic aneurysm planned to receive urgent or emergent repair within 48 hours of...
What rules you out
- 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 treatment 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...
- 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...
- 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...
- Body habitus that would inhibit X-ray visualization of the aorta and its branches. Anatomic Exclusion Criteria
- Inadequate femoral or iliac access compatible with the required delivery systems.
- Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access.
- Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:
- A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm;
- Parallel aortic wall with \<20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
- Visceral vessel anatomy not compatible with fenestrated/branched stent graft visceral vessel incorporation due to excessive occlusive disease or small size not amenable to stent graft placement
- Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or iliac branch device as per devices' instructions for use (IFU)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.