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Endovascular Stent Graft
B-TEVAR Device for Aortic Aneurysm (B-TEVAR Trial)
N/A
Recruiting
Led By Matthew P Sweet, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is > 18 years of age
The patient has no more than 5 necessary visceral arteries that require flow preservation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
B-TEVAR Trial Summary
This trial is looking at whether branched and fenestrated-branched stent grafts are safe and effective for treating patients with thoraco-abdominal aortic aneurysms. The study will enroll patients consecutively and compare outcomes between different types of stent grafts.
Who is the study for?
Adults over 18 with thoraco-abdominal aortic aneurysms needing branch vessel preservation, who are not pregnant and have a life expectancy over 1 year. Candidates must be at high risk for open surgery due to other health issues and agree to follow-up exams. Exclusions include active infections, certain allergies, unmanageable contrast media hypersensitivity, unstable angina, or participation in another trial.Check my eligibility
What is being tested?
The safety and effectiveness of Cook Medical's branched and fenestrated-branched endovascular stent grafts for preserving vital arteries in patients with thoraco-abdominal aortic aneurysms are being tested. This non-randomized study involves off-the-shelf and custom-made devices.See study design
What are the potential side effects?
Potential side effects may include complications related to the device such as movement after placement, blockage of blood flow through the graft or branches leading to organ damage or loss of limb function; infection; allergic reactions; bleeding; or clotting.
B-TEVAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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No more than 5 of my vital arteries need to be kept open.
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My aortic aneurysm affects major arteries in my chest and abdomen.
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My arteries are suitable for a specific medical device delivery.
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My aortic aneurysm is larger than 5.5 cm, has grown, or is causing symptoms.
B-TEVAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The effectiveness of multi-branched endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success
Secondary outcome measures
Mortality rates
Other outcome measures
Technical Success
B-TEVAR Trial Design
1Treatment groups
Experimental Treatment
Group I: B -TEVARExperimental Treatment1 Intervention
Implantation of the B-TEVAR device
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,818 Total Patients Enrolled
Matthew P Sweet, MDPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to contrast dye and can't be treated before using it.The patient is expected to live for more than 1 year.All important blood vessels in the body are wider than 4 millimeters.No more than 5 of my vital arteries need to be kept open.I am a man or a woman not currently pregnant (women must test negative for pregnancy before joining).I have worsening chest pain, including at rest or at night.My doctor thinks surgery is too risky for me due to my other health issues.My heart and main blood vessels are suitable for a secure and leak-free attachment.I cannot take blood thinners due to a specific medical reason.My thoracoabdominal aortic aneurysm has burst and is causing unstable blood pressure.I have not had major surgery unrelated to my aneurysm treatment planned within the next 30 days.I am older than 18 years.I currently have an infection that affects my whole body.I have an aneurysm caused by an infection.Your body shape makes it hard to see your aorta clearly on an X-ray.My aortic aneurysm affects major arteries in my chest and abdomen.My arteries are suitable for a specific medical device delivery.You have a history of connective tissue diseases like Marfan or Ehlers Danlos syndromes.You are allergic to stainless steel, nickel, or gold.My spine's main blood supply comes from an area that can't be saved during a specific graft procedure.My aortic aneurysm is larger than 5.5 cm, has grown, or is causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: B -TEVAR
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.
Are there any unfilled vacancies for participants in the trial?
"Currently, this medical trial is recruiting individuals to participate. It was originally posted on August 1st 2012 and the details were most recently amended on August 10th 2021."
Answered by AI
How many participants are able to join this medical experiment?
"Affirmative, according to clinicaltrials.gov the trial is actively recruiting patients with a commencement date of August 1st 2012 and most recent update from August 10th 2021. A total of 120 people will be accepted across one site."
Answered by AI
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