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Stent-Graft

Stent-Graft for Aortic Aneurysm

N/A
Recruiting
Led By Linda M Reilly, MD
Research Sponsored by Timothy Chuter, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aneurysm of the aortic arch larger than 6cm in diameter, or symptomatic aneurysm of the aortic arch, of any diameter, or any arch aneurysm with a 2-year rupture rate estimated to be more than 20%.
Suitable arterial anatomy for stent-graft
Must not have
Serious systemic or groin infection
Significant presence of carotid artery atherosclerosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new operation to fix aortic aneurysms that involves placing a stent-graft over the aneurysm.

Who is the study for?
This trial is for individuals with aortic arch aneurysms larger than 6cm, symptomatic of any size, or at high risk of rupture. Candidates must be able to consent and follow the study plan, have a life expectancy over 2 years, and not suitable for open repair surgery due to high mortality risk.
What is being tested?
The study tests the safety and effectiveness of using an endovascular bifurcated stent-graft to treat aortic arch aneurysms. The procedure involves placing this special tube inside the artery without open surgery.
What are the potential side effects?
Potential side effects may include complications related to the device like movement after placement, blockage or infection; reactions from contrast material used during implantation; and general risks associated with minimally invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a large or symptomatic aortic arch aneurysm, or one likely to rupture.
Select...
My arteries are suitable for a stent-graft procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious infection in my body or groin area.
Select...
I have significant blockage in my neck arteries.
Select...
I have a blood clotting disorder that cannot be corrected.
Select...
My aneurysm has burst.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: InterventionalExperimental Treatment1 Intervention
Endovascular Bifurcated Stent Graft: The investigational operation involves placing a stent-graft over the aortic aneurysm.

Find a Location

Who is running the clinical trial?

Timothy Chuter, MDLead Sponsor
1 Previous Clinical Trials
250 Total Patients Enrolled
Linda M Reilly, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Endovascular Bifurcated Stent-Graft (Stent-Graft) Clinical Trial Eligibility Overview. Trial Name: NCT00488696 — N/A
Aortic aneurysm Research Study Groups: Interventional
Aortic aneurysm Clinical Trial 2023: Endovascular Bifurcated Stent-Graft Highlights & Side Effects. Trial Name: NCT00488696 — N/A
Endovascular Bifurcated Stent-Graft (Stent-Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00488696 — N/A
~1 spots leftby Dec 2025
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