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Endovascular Stent-Graft System
Endograft for Aortic Aneurysm
N/A
Recruiting
Led By W. Anthony Lee, MD
Research Sponsored by Lee, W. Anthony, M.D. FACS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient must have one of the following: Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular) with a diameter of ≥55mm in a male or ≥50mm in a female, or Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or Penetrating ulcers with a depth of ≥20mm, or Chronic type B aortic dissections with a total aortic diameter of ≥50mm, or Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0-day 30 (early) day 31-1825 (late)
Awards & highlights
Study Summary
This trial will help researchers learn more about the safety and effectiveness of the Cook Zenith t-Branch endovascular stent-graft system for treating aortic aneurysms.
Who is the study for?
This trial is for adults with certain types of aortic aneurysms, including those that are large, growing quickly, or symptomatic. Participants need to have specific measurements related to their aneurysm and access vessels. Excluded are individuals under 18, pregnant women, those with short life expectancy or uncontrollable allergies to contrast dye.Check my eligibility
What is being tested?
The study is evaluating the Zenith t-Branch endovascular stent-graft system in treating aortic aneurysms. It aims to gather data on its effectiveness and safety when used in real-world medical settings.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications from the device such as blood vessel damage during insertion, movement of the graft after placement, leakage around the graft (endoleak), blockage or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific type of large or growing aortic aneurysm, ulcer, or dissection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0-day 30 (early) day 31-1825 (late)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0-day 30 (early) day 31-1825 (late)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Early Mortality
Secondary outcome measures
Rates of Neurologic Complications/Late Branch Vessel Patency
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Treatment ArmExperimental Treatment1 Intervention
All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.
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Who is running the clinical trial?
Lee, W. Anthony, M.D. FACSLead Sponsor
William Cook AustraliaIndustry Sponsor
4 Previous Clinical Trials
979 Total Patients Enrolled
1 Trials studying Thoracoabdominal Aortic Aneurysms
530 Patients Enrolled for Thoracoabdominal Aortic Aneurysms
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,606 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than a year.The angle between the neck and the aneurysm is less than 90 degrees.The Zenith® t-Branch device cannot be inserted in me through the iliofemoral approach.I have a specific type of large or growing aortic aneurysm, ulcer, or dissection.I have an abnormal connection between my aorta and another organ.I am under 18 years old.The section of the aorta or iliac arteries where the device would be placed is too short.I do not have an untreated or uncontrolled infection.The diameter of the lower part of the aorta is too small or too big, or the diameter of the iliac arteries is too small or too big.The diameter of the landing zone in the blood vessel is too small or too large.You have severe allergic reactions to iodine-based contrast dye that cannot be controlled.The area where the device will be placed is too short for it to be securely attached and sealed.I have an infection caused by fungi.You are allergic to the materials used in the device.My cancer cannot be cured with treatment.My leg arteries are too narrow or blocked for standard access.I refuse to receive blood transfusions.
Research Study Groups:
This trial has the following groups:- Group 1: Single Treatment Arm
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.
What is the enrollment size for this clinical research endeavor?
"Affirmative. Details available on clinicaltrials.gov verify that this medical experiment, which was launched on January 25th 2012, is actively recruiting participants. This trial needs to enroll 225 patients from a single clinical site."
Answered by AI
Has enrollment for this trial commenced?
"According to the information provided on clinicaltrials.gov, this trial is currently in need of participants. It was initially published on January 25th 2012 and underwent its most recent update on December 22nd 2021."
Answered by AI
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