← Back to Search

Stent Graft

Modified Stent Grafts for Aortic Aneurysm (Assets Trial)

N/A

Waitlist Available

Research Sponsored by Jesse Manunga, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject has one or more of the following: An aneurysm with a maximum diameter of > 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal measurements, Aneurysm with a history of growth > 0.5 cm in 6 months or clinically indicated for repair based on symptoms, Symptomatic aneurysm, Ruptured aneurysm, Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss, Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture, High risk for open surgical repair based on anatomic and physiological factors

Anatomical Inclusion Criteria: Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, Extent of aorta to be treated, Non-aneurysmal aortic segment proximal to the aneurysm (neck) with specific criteria

Must not have

Inability or unwillingness of patient or patient's legally authorized representative to provide informed consent

Anatomical Exclusion Criteria: Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access, Proximal neck length ≤20 mm, Specific criteria for different types of endovascular grafts, Iliac artery diameter, Ipsilateral iliac artery fixation site diameter, Non-bifurcated segment of any artery to be stented, Artery to be stented with a maximum diameter, Inability to maintain at least one patent hypogastric artery, Bilateral renal artery stenosis, Superior mesenteric artery stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the safety and effectiveness of a new type of stent graft for people who have had failed previous aortic aneurysm repairs.

Who is the study for?

This trial is for adults with complex aortic aneurysms or failed previous infrarenal repairs, who are at high risk for open surgery. Candidates must have certain aneurysm sizes or symptoms and suitable anatomy for the procedure. Pregnant women, those under 18, patients with allergies to device materials, uncorrectable coagulopathy, or severe kidney issues cannot participate.

What is being tested?

The trial tests surgeon-modified fenestrated stent grafts on patients with complex aortic aneurysms or prior unsuccessful endovascular repairs. It aims to assess safety and effectiveness of these custom-made devices in managing life-threatening aortic conditions.

What are the potential side effects?

Potential side effects may include complications related to the stent graft placement such as blood vessel damage, infection risks associated with any surgical intervention, allergic reactions to materials used in the stents or contrast media during imaging procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have an aneurysm that is larger than a specific size, has grown quickly, is causing symptoms, has ruptured, or has not responded well to previous treatment.

Select...

My blood vessels are suitable for surgery, and I have a specific type of aortic condition.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot or do not want to give consent for the trial.

Select...

My blood vessels may not be suitable for certain types of stent placements.

Select...

I am eligible for treatment with a standard, approved vascular device.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prevention of aortic aneurysm related mortality and all cause mortality post intervention

Secondary study objectives

Endoleak

Adrenal gland hypofunction

Issues associated with disease progression, branched instability, endoleak and other disabling complications as evaluated on post-operative follow up and radiographic images.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Thoracoabdominal aortic aneurysm extent I-IIIExperimental Treatment1 Intervention

Thoracoabdominal aortic aneurysm extent I-III (proximal seal can be from the left carotid artery to directly after the left subclavian artery):

Group II: Failed EVARExperimental Treatment1 Intervention

Failed EVAR (defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss)/juxtarenal/Pararenal/paravisceral/thoracoabdominal aortic aneurysm extent IV-V:

0 / 7Eligibility criteria met