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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a large or symptomatic aortic arch aneurysm, or one likely to rupture.
Select...
My arteries are suitable for a stent-graft procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful implantation of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch
Secondary outcome measures
Stability of bifurcated stent-graft for repair of Aneurysm involving the proximal aortic arch
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.
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Who is running the clinical trial?
Timothy Chuter, MDLead Sponsor
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Aortic Aneurysm
250 Patients Enrolled for Aortic Aneurysm
Linda M Reilly, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Aortic Aneurysm
300 Patients Enrolled for Aortic Aneurysm
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart rhythm problem but it's managed with a pacemaker.I have a serious infection in my body or groin area.I have significant blockage in my neck arteries.The expected chance of not surviving surgery is more than 20%.You are expected to live for more than 2 years.You are allergic to stainless steel or polyester.I have a blood clotting disorder that cannot be corrected.You have had a severe allergic reaction to contrast material.I have a large or symptomatic aortic arch aneurysm, or one likely to rupture.My arteries are suitable for a stent-graft procedure.My aneurysm has burst.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team actively enrolling participants for this experiment?
"Yes, according to the information available on clinicaltrials.gov, this medical trial is still in search of participants. It was first posted back on October 1st 2006 and then updated most recently on July 21st 2021. Currently they are looking for 25 patients at a single location."
Answered by AI
What is the sample size of participants in this research endeavor?
"Affirmative. Clinicaltrials.gov shows that this trial, first created on October 1st 2006, is currently seeking recruits; 25 individuals in total from a single clinical site are needed to complete the study."
Answered by AI
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