Is NCT06526676 recruiting in Los Angeles, CA?

Yes, NCT06526676 is currently recruiting participants at its Los Angeles, CA location. This juxtarenal aortic aneurysm clinical trial is actively enrolling qualified participants.

How do I join the juxtarenal aortic aneurysm clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Juxtarenal Aortic Aneurysm Clinical Trial in Los Angeles, CA

About This Juxtarenal Aortic Aneurysm Study in Los Angeles

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.

Sponsor: University of California, Los Angeles

Who Can Participate

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)

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 inclusion criteria 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 diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.

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 morphology with no suitable landing zone proximal to iliac bifurcation.

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 clinical encounter, in patients able to provide informed consent and deemed not a reasonable candidate for open surgery or repair with any commercially available device.

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. Medical Exclusion Criteria:

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).

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT06526676) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Juxtarenal Aortic Aneurysm Treatment Options in Los Angeles, CA

If you're searching for juxtarenal aortic aneurysm treatment options in Los Angeles, CA, this clinical trial (NCT06526676) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this clinical trial. You'll receive care from experienced juxtarenal aortic aneurysm specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all juxtarenal aortic aneurysm clinical trials near you to find additional studies recruiting in your area.

Juxtarenal Aortic Aneurysm Clinical Trial in Los Angeles, CA

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