Is NCT05339061 recruiting in San Diego, CA?

Yes, NCT05339061 is currently recruiting participants at its San Diego, CA location. This complex abdominal aortic aneurysm clinical trial is actively enrolling qualified participants.

Is participation in this San Diego 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.

Complex Abdominal Aortic Aneurysm Clinical Trial in San Diego, CA

Q: How do I join the complex abdominal aortic aneurysm clinical trial in San Diego?

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

About This Complex Abdominal Aortic Aneurysm Study in San Diego

The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.

Sponsor: University of California, Davis

Who Can Participate

Inclusion Criteria

Patient is \> 18 years of age

Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)

Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form

Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:

Aortic aneurysm with diameter ≥ 5.5cm

Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months

Symptomatic aortic aneurysm

Cannot be treated with a currently available non-modified approved device

High risk for open surgical repair based on any of the factors below:

Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery

Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD

Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit

Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm

Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.

The resultant repair should preserve patency in at least one hypogastric artery.

Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm

Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm. ---

Exclusion Criteria

--- -General Exclusion Criteria-

Patient has a mycotic aneurysm

Patient has a ruptured aneurysm requiring urgent or emergent repair

Patient has a systemic or local infection that may increase the risk of graft infection

Patient has a body habitus that would inhibit X-ray visualization of the aorta.

Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution

Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair.

Patient is currently participating in another investigational device or drug clinical trial. -Medical Exclusion Criteria-

Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.

Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.

Patient has uncorrectable coagulopathy

Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)

Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).

Patient has active malignancy with life expectancy of less than 2 years

Patient has a limited life expectancy of less than 2 years.

Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations. -Anatomic Exclusion Criteria-

Significant occlusive disease, tortuosity or calcification that would prevent endovascular access

Proximal seal site with a circumferential thrombus/atheroma

Inability to maintain at least one patent hypogastric artery

Shaggy aorta

Patient is not amenable to a temporary or permanent open surgical or endovascular conduit

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 San Diego?

Yes, this clinical trial (NCT05339061) has an active research site in San Diego, 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.

Complex Abdominal Aortic Aneurysm Treatment Options in San Diego, CA

If you're searching for complex abdominal aortic aneurysm treatment options in San Diego, CA, this clinical trial (NCT05339061) 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 San Diego research site is actively enrolling participants for this clinical trial. You'll receive care from experienced complex abdominal 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 complex abdominal aortic aneurysm clinical trials near you to find additional studies recruiting in your area.

Complex Abdominal Aortic Aneurysm Clinical Trial in San Diego, CA

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IRB Approved

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