Endovascular Graft + Covered Stent for Abdominal Aortic Aneurysm

Recruiting at 26 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cook Research Incorporated

Disqualifiers: Age <18, Life expectancy <2 years, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Research Team

Mark Farber, MD

Principal Investigator

University of North Carolina

Eligibility Criteria

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.

Inclusion Criteria

My abdominal aortic aneurysm is growing more than 0.5 cm a year.

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.

Exclusion Criteria

I am under 18 years old.

I cannot or will not give my consent to participate.

Pregnant, breast-feeding, or planning on becoming pregnant within 60 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Zenith® p-Branch® Endovascular Graft

Trial Overview 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.

Participant Groups

Group I: Endovascular Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Cook Research Incorporated

Lead Sponsor

Trials

31

Recruited

254,000+