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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
Additional criteria for LP material: Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0-day 30 (early) day 31-1825 (late)
Awards & highlights
No Placebo-Only Group

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 below
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My leg arteries are too narrow or blocked for standard access.
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I have a specific type of large or growing aortic aneurysm, ulcer, or dissection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0-day 30 (early) day 31-1825 (late)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0-day 30 (early) day 31-1825 (late) for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

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
7,646 Total Patients Enrolled

Media Library

Zenith® t-Branch (Endovascular Stent-Graft System) Clinical Trial Eligibility Overview. Trial Name: NCT01524211 — N/A
Thoracoabdominal Aortic Aneurysms Research Study Groups: Single Treatment Arm
Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: Zenith® t-Branch Highlights & Side Effects. Trial Name: NCT01524211 — N/A
Zenith® t-Branch (Endovascular Stent-Graft System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01524211 — N/A

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
~88 spots leftby Dec 2031