Endovascular Graft + Covered Stent for Abdominal Aortic Aneurysm

No longer recruiting at 28 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for abdominal aortic aneurysms, which are bulges or swellings in the main blood vessel that carries blood from the heart to the body. The researchers aim to determine if the Zenith® p-Branch® endovascular graft, used with Atrium iCAST™ covered stents, is safe and effective. Suitable participants have an abdominal aortic aneurysm at least twice the normal size or one that has been growing rapidly. As an unphased trial, this study allows patients to contribute to pioneering research that could lead to innovative treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this endovascular graft and covered stent are safe for treating abdominal aortic aneurysms?

Research has shown that the Zenith® p-Branch® Endovascular Graft, used with Atrium iCAST™ covered stents, has been tested on individuals with abdominal aortic aneurysms. In one study, 30 patients received this treatment, and it succeeded in 93% of cases, indicating effectiveness for most participants.

Regarding safety, the treatment was generally well-tolerated, meaning most individuals did not experience serious issues afterward. However, like any medical procedure, some risks or side effects may occur. The study aimed to minimize these risks and manage them effectively.

While researchers continue to study this treatment for this specific condition, its approval for a clinical trial by the FDA suggests it is reasonably safe. If considering participation, discussing potential risks and benefits with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zenith® p-Branch® Endovascular Graft because it offers a minimally invasive alternative to traditional open surgery for abdominal aortic aneurysms. This treatment uses a unique combination of the Zenith® p-Branch® graft and Atrium iCAST™ covered stents, which can be precisely placed inside the blood vessel without the need for large incisions. Unlike conventional surgical options, this approach could reduce recovery time and complications, making it a promising option for patients who are high-risk surgical candidates.

What evidence suggests that the Zenith® p-Branch® endovascular graft is effective for abdominal aortic aneurysms?

Research has shown that the Zenith® p-Branch® endovascular graft, used with Atrium iCAST™ covered stents, may effectively treat abdominal aortic aneurysms. In one study with 30 patients, the procedure was successfully completed as planned in 93% of cases, with no major issues. Patients who received this treatment generally experienced good results over time. Another study with similar devices reported positive outcomes over five years, suggesting long-term effectiveness. These findings indicate that this treatment, currently being tested in this trial, could be a reliable option for people with this condition. ^{4 5 6 7 8}

Who Is on the Research Team?

Mark Farber, MD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23611709/

Zenith p-branch standard fenestrated endovascular graft ... Objective: This article reports the early clinical outcomes and experiences of Zenith pivot branch device (p-branch) standard fenestrated endovascular graft ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01652235

Zenith® p-Branch® and Zenith® Fenestrated AAA ... The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and ...

3. jvascsurg.org jvascsurg.org/article/S0741-5214(20)32014-0/fulltext

Final 5-year results of the United States Zenith Fenestrated ... To report 5-year results of the prospective, multicenter study designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (William ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S074152141930518X

Results from a prospective multicenter feasibility study of ... Key Findings: Thirty patients were treated for pararenal abdominal aortic aneurysms with the Zenith p-Branch stent graft. Technical success was 93% and renal ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20205742

A Study of the Zenith® p-Branch® Endovascular Graft for ... The purpose of the Zenith® p-Branch® Pivotal clinical trial is to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination ...

6. jvascsurg.org jvascsurg.org/article/S0741-5214(19)30518-X/fulltext

Results from a prospective multicenter feasibility study of ... Key Findings: Thirty patients were treated for pararenal abdominal aortic aneurysms with the Zenith p-Branch stent graft. Technical success was ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf2/P020018S064B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of endovascular treatment with the Zenith® Iliac Branch ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02396199

Zenith® p-Branch® Endovascular Graft Pivotal Study 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 ...