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Endovascular Graft

Endovascular Graft + Bridging Stent for Aortic Aneurysm

N/A

Recruiting

Led By Gustavo Oderich, 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

Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm

Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post procedure

Awards & highlights

Study Summary

This trial will assess a new medical device to treat aortic aneurysms involving one or more of the major arteries.

Who is the study for?

This trial is for adults with large or rapidly growing aortic aneurysms near the major arteries from the chest to the abdomen. Candidates must not be pregnant, planning pregnancy within 5 years, or involved in other studies. They should expect to live more than 2 years and agree to follow-up visits.Check my eligibility

What is being tested?

The study tests the Zenith® Fenestrated+ Endovascular Graft combined with BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System on patients with complex aortic aneurysms, evaluating its safety and effectiveness in treating these conditions.See study design

What are the potential side effects?

While specific side effects are not listed here, endovascular graft procedures may include risks such as blood vessel damage, infection, bleeding complications, stent migration or failure leading to potential surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My aortic aneurysm is 50 mm or larger.

Select...

My aortic aneurysm has grown 5 mm or more in 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite measure of device technical success and procedural safety

Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aortic abdominal aneurysmExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cook Research IncorporatedLead Sponsor

30 Previous Clinical Trials

253,951 Total Patients Enrolled

Gustavo Oderich, MDPrincipal InvestigatorMemorial Hermann Texas Medical Center

1 Previous Clinical Trials

200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this clinical trial thus far?

"Yes, the information on clinicaltrials.gov confirms that enrollment is underway for this trial; it was originally posted in November 1st 2023 and saw its last update 6 days ago. 102 participants are being recruited from a single site."

Answered by AI

Are there still open slots available for participants of this research experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this research initiative is currently open for enrolment. Initially posted on the 1st of November 2021, and most recently revised on the 6th of November 2021, this trial seeks 102 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zenith® Fenestrated+ Clinical Study

2023. "Zenith® Fenestrated+ Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04875429.

All > Abdominal Aortic Aneurysm