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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My abdominal aorta is enlarged to 5.0 cm or twice its normal size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment Success Proportion
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
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Who is running the clinical trial?
Cook Research IncorporatedLead Sponsor
30 Previous Clinical Trials
253,973 Total Patients Enrolled
Mark A Farber, MDPrincipal InvestigatorUniversity of North Carolina
2 Previous Clinical Trials
675 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.My abdominal aortic aneurysm is growing more than 0.5 cm a year.I cannot or will not give my consent to participate.My abdominal aorta is enlarged to 5.0 cm or twice its normal size.My aneurysm is at risk of bursting according to my doctor.You are not expected to live for at least 2 more years.
Research Study Groups:
This trial has the following groups:- Group 1: Endovascular
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active 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 geographic extent of this research experiment?
"Currently, 27 different medical sites are recruiting patients for this trial. Notable cities include Atlanta, New york and Stanford. To diminish the need to travel excessively far, it is recommended that individuals seek out the closest location they can access if they decide to participate."
Answered by AI
Are there any opportunities for individuals to join this experiment?
"Information contained on clinicaltrials.gov suggests that recruitment for this study has ceased, with the original posting being made in August of 2015 and an updated version released October 3rd 2022. Despite its dormancy, there are 153 other trials actively seeking volunteers at present."
Answered by AI
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