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Endovascular Graft

Endovascular Graft + Covered Stent for Abdominal Aortic Aneurysm

N/A
Waitlist Available
Led By Mark A Farber, MD
Research Sponsored by Cook Research Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
Be older than 18 years old
Must not have
Age <18 years
Inability or refusal to give informed consent by the patient or a legally authorized representative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new endovascular graft in combination with a covered stent to treat abdominal aortic aneurysms. The goal is to see if this new treatment is safe and effective.

Who is the study for?
This trial is for adults with a specific type of bulging artery in their abdomen (abdominal aortic aneurysm) that's at risk of bursting. It's not for those under 18, pregnant or planning pregnancy within five years, unable to consent, unwilling to follow the study plan, involved in another study recently, or expected to live less than two more years.
What is being tested?
The Zenith® p-Branch® Pivotal Study tests the safety and effectiveness of the Zenith® p-Branch® graft combined with Atrium iCAST™ covered stents in treating abdominal aortic aneurysms. The FDA has approved this trial.
What are the potential side effects?
While specific side effects are not listed here, endovascular procedures like this can generally cause complications such as bleeding, infection at the incision site, blood vessel damage, and reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My abdominal aorta is enlarged to 5.0 cm or twice its normal size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I cannot or will not give my consent to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment Success Proportion

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: EndovascularExperimental Treatment1 Intervention
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents

Find a Location

Who is running the clinical trial?

Cook Research IncorporatedLead Sponsor
30 Previous Clinical Trials
253,787 Total Patients Enrolled
Mark A Farber, MDPrincipal InvestigatorUniversity of North Carolina
2 Previous Clinical Trials
675 Total Patients Enrolled

Media Library

Zenith® p-Branch® Endovascular Graft (Endovascular Graft) Clinical Trial Eligibility Overview. Trial Name: NCT02396199 — N/A
Abdominal Aortic Aneurysm Research Study Groups: Endovascular
Zenith® p-Branch® Endovascular Graft (Endovascular Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02396199 — N/A
Abdominal Aortic Aneurysm Clinical Trial 2023: Zenith® p-Branch® Endovascular Graft Highlights & Side Effects. Trial Name: NCT02396199 — N/A
~8 spots leftby Nov 2025
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