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Endovascular Stent Graft

B-TEVAR Device for Aortic Aneurysm (B-TEVAR Trial)

Seattle, WA
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
Must not have
Patient has an absolute contra-indication to anticoagulation
Patient has a freely ruptured TAAA with hemodynamic instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.

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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.

Eligibility Criteria

Inclusion Criteria

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

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take blood thinners due to a specific medical reason.
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My thoracoabdominal aortic aneurysm has burst and is causing unstable blood pressure.
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I have worsening chest pain, including at rest or at night.
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I currently have an infection that affects my whole body.
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I have an aneurysm caused by an infection.
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My spine's main blood supply comes from an area that can't be saved during a specific graft procedure.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Technical Success

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: B -TEVARExperimental Treatment1 Intervention
Implantation of the B-TEVAR device

Find a Location

Closest Location:University of Washington/Harborview Medical Center· Seattle, WA· 2011 miles

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,853 Previous Clinical Trials
2,021,571 Total Patients Enrolled
Matthew P Sweet, MDPrincipal InvestigatorUniversity of Washington

Media Library

B-TEVAR device (Endovascular Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT01874197 — N/A
Aortic aneurysm Research Study Groups: B -TEVAR
Aortic aneurysm Clinical Trial 2023: B-TEVAR device Highlights & Side Effects. Trial Name: NCT01874197 — N/A
B-TEVAR device (Endovascular Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01874197 — N/A
~7 spots leftby Aug 2025
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