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Endovascular Device
Endovascular Aneurysm Repair for Aortic Aneurysm
N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.
Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
Awards & highlights
Study Summary
This trial intends to treat complex aortic aneurysms in high-risk patients with modified endografts. Subjects will be followed for five years and monitored for major adverse events.
Who is the study for?
This trial is for high-risk patients over 18 with complex aortic aneurysms who can't use FDA-approved endografts but have suitable anatomy for a modified version. They must not be pregnant, have good vascular access, and agree to long-term follow-up. Excluded are those with infections, allergies to device materials, other serious health issues or conditions affecting the study participation.Check my eligibility
What is being tested?
The trial tests a physician-modified endograft on patients with complex aortic aneurysms. It aims to cover renal arteries and others in cases where standard options aren't viable. The study will enroll 40 subjects at one site over two years and follow them for five years, assessing safety within the first month and effectiveness after one year.See study design
What are the potential side effects?
Potential side effects may include complications related to the graft such as infection or allergic reactions to its components (stainless steel, polyester etc.), problems from invasive procedures like bleeding or clotting issues, and general risks associated with endovascular surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lower artery near the hip is long enough for a safe procedure.
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My lower artery size is between 7 and 20 mm and not bulging.
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I am older than 18 years.
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My iliac or femoral arteries are suitable for a specific type of endovascular procedure.
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My aorta near my heart is long enough for a safe procedure.
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My aorta's upper part is the right size and not an aneurysm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary effectiveness endpoint
The Primary Safety Endpoint (Freedom from major adverse events [MAE])
Secondary outcome measures
Follow-up outcomes
Technical success
The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days
Trial Design
1Treatment groups
Experimental Treatment
Group I: Physician-Modified EndograftExperimental Treatment1 Intervention
This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysms (Extent I-V).
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,520,884 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My lower artery near the hip is long enough for a safe procedure.My doctor expects I have less than 2 years to live due to my cancer.Aorta with a disorganized or irregular appearance.You have a known severe allergic reaction to blood thinners or contrast dye that cannot be treated before the study.I cannot keep at least one main artery in my lower abdomen open.I cannot have surgery or procedures to open blocked vessels.I have a complex aneurysm in my upper abdomen or chest.My blood vessel has a clot or plaque at the site needing a seal.I am a man or a woman not currently pregnant (if capable of bearing children, I have a negative pregnancy test).My lower artery size is between 7 and 20 mm and not bulging.I am considered high risk for traditional surgery.I am older than 18 years.My iliac or femoral arteries are suitable for a specific type of endovascular procedure.I have an aneurysm caused by an infection.I have an infection that could affect a surgical graft.I need urgent surgery for a burst blood vessel.Your body shape makes it hard to see your aorta on an X-ray.I have a major surgery planned around the time of my AAA repair.I have a blood clotting disorder that cannot be corrected.My surgery will keep at least one artery in my pelvis open.You have a history of connective tissue diseases like Marfan's or Ehlers-Danlos syndrome.I have severe blockage or hardening in my blood vessels that could hinder procedures.You are expected to live for less than 2 years.I have worsening chest pain, including at rest or at night.My aorta near my heart is long enough for a safe procedure.My aorta's upper part is the right size and not an aneurysm.
Research Study Groups:
This trial has the following groups:- Group 1: Physician-Modified Endograft
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.
How many participants is the team recruiting for this research study?
"Affirmative. Clinicaltrials.gov records show that this research project, which was originally advertised on March 1st 2023, is searching for participants. 40 individuals need to be recruited from a singular clinical centre."
Answered by AI
Is this experiment currently recruiting participants?
"Affirmative. The relevant information on clinicaltrials.gov reveals that recruitment is in progress for this medical research project, first announced on March 1st 2023 and most recently edited on the 10th of March 2023. 40 participants are required to be enrolled from one centre."
Answered by AI
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