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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years
Awards & highlights
Assets Trial 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.Check my eligibility
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.See study design
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.
Assets Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Assets Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevention of aortic aneurysm related mortality and all cause mortality post intervention
Secondary outcome measures
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 moreAssets 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:
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Who is running the clinical trial?
Jesse Manunga, MDLead Sponsor
Minneapolis Heart Institute FoundationOTHER
29 Previous Clinical Trials
15,440 Total Patients Enrolled
1 Trials studying Aortic Aneurysm
102 Patients Enrolled for Aortic Aneurysm
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or do not want to give consent for the trial.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.My blood vessels are suitable for surgery, and I have a specific type of aortic condition.I see several exclusion criteria for the medical study:
- You are allergic to the materials used in the devices.
- You are allergic to anticoagulation or contrast media.
- You have a blood clotting problem that cannot be corrected.
- Your body shape makes it hard to see your aorta using x-rays.
- You had major surgery or a procedure not related to treating the planned aneurysm within the last 30 days.
- You have unstable angina (chest pain).
- You have an infection that could increase the risk of endovascular graft infection.
- Your baseline creatinine level is higher than 2.0 mg/dL.
- You have a history of certain connective tissue disorders, except if you've had a previous open surgical aortic replacement.My blood vessels may not be suitable for certain types of stent placements.Your overall health status is classified as low, medium, or high risk according to specific assessment systems.I am eligible for treatment with a standard, approved vascular device.I am under 18 years old.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Thoracoabdominal aortic aneurysm extent I-III
- Group 2: Failed EVAR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently accepting participants?
"Clinicaltrials.gov reveals that, despite first being posted on October 1st 2022 and lastly edited three days later, this medical trial is not currently recruiting individuals. However, 152 other trials are actively accepting patients at the moment."
Answered by AI
What are the desired results of this clinical research?
"This clinical trial will monitor two main goals over the course of 5 years: prevention of aortic aneurysm-related mortality and all-cause mortality post intervention. Secondary outcomes to be monitored encompass target vessel instability leading to patient adversity, such as mesenteric ischemia or renal failure, procedure related complications like stroke or myocardial infarction, and additional issues associated with disease progression including endoleak and secondary interventions that limit lifestyle choices or cause disability."
Answered by AI
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