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Stent Graft
Endovascular Repair for Thoracoabdominal Aortic Aneurysm
N/A
Waitlist Available
Research Sponsored by Matthew Eagleton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
Proximal landing zone for the thoracic bifurcation stent graft that has: ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) and a diameter in the range of 26-42 mm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at each follow-up interval (five years)
Awards & highlights
Study Summary
This trial is testing a new device to treat thoracoabdominal aortic aneurysms. The primary goal is to assess safety and preliminary effectiveness.
Who is the study for?
This trial is for adults with thoracoabdominal aortic aneurysms that have grown or are symptomatic. Candidates should have specific measurements in their arteries to fit the stent graft and must not be good candidates for open surgery or other treatments. They need at least a year's life expectancy, compatible vessel morphology, and willingness to follow up.Check my eligibility
What is being tested?
The Valiant Thoracoabdominal Stent Graft System is being tested for safety and effectiveness in repairing thoracoabdominal aortic aneurysms. The study will evaluate how well it works immediately after placement and over time during follow-up checks.See study design
What are the potential side effects?
Potential side effects may include risks related to endovascular procedures such as blood vessel damage, infection risk from the procedure, allergic reactions to materials in the stent graft system, or complications like blockage of blood flow.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My artery or graft site for fixation is the right size and length.
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My aorta near the left shoulder has a healthy section for a stent and is 26-42 mm wide.
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I am 18 years old or older.
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My aneurysm grew more than 0.5 cm in 6 months.
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My aneurysm is at high risk of bursting.
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I have a large aneurysm causing symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1- year post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1- year post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from MAEs (at 30 Days)
Preliminary Effectiveness (treatment and technical success)
Secondary outcome measures
Technical Success
Treatment Success
Trial Design
2Treatment groups
Experimental Treatment
Group I: Primary Study ArmExperimental Treatment1 Intervention
The Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Group II: Expanded Use ArmExperimental Treatment1 Intervention
The Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. The expanded use arm provides broaden inclusion criteria to include select patients excluded from the primary study arm.
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Who is running the clinical trial?
MedtronicIndustry Sponsor
607 Previous Clinical Trials
828,660 Total Patients Enrolled
2 Trials studying Thoracoabdominal Aortic Aneurysms
19 Patients Enrolled for Thoracoabdominal Aortic Aneurysms
NAMSAOTHER
46 Previous Clinical Trials
18,817 Total Patients Enrolled
Sanford HealthOTHER
48 Previous Clinical Trials
61,908 Total Patients Enrolled
1 Trials studying Thoracoabdominal Aortic Aneurysms
15 Patients Enrolled for Thoracoabdominal Aortic Aneurysms
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a contained rupture.I have a blood clot or severe hardening in the upper part of my aorta.The blood vessels in the area where the treatment will be done are too small.I have had a major surgery not related to aneurysm treatment within the last 30 days.My anatomy allows for at least one open hypogastric artery.I have an infection that could risk a graft infection.I have a blood clotting disorder that cannot be corrected.I have unstable chest pain.I have an aneurysm larger than 5.5 cm or twice the size of the normal artery near it.My artery or graft site for fixation is the right size and length.My anatomy prevents proper blood flow in my left subclavian artery.I qualify for the study but have a small vessel diameter of less than 5mm.You are allergic to the materials used to make the medical devices, such as nickel-titanium, polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.My aorta near the left shoulder has a healthy section for a stent and is 26-42 mm wide.I am 18 years old or older.My blood vessels are suitable for certain medical procedures or device insertions.I have a tear in the main artery intended for treatment.My aneurysm grew more than 0.5 cm in 6 months.I have had a procedure to open blocked arteries in my abdomen.You have a history of disorders that affect your connective tissues.Your body size makes it difficult to take a clear x-ray of your aorta.I have had a ruptured aneurysm.There needs to be enough space from the celiac artery for inserting a tube from the front access point.My aneurysm is at high risk of bursting.I am allergic or react badly to blood thinners or contrast dyes that can't be managed with medication.I had surgery to repair an aneurysm and may need a new procedure that goes beyond the previous repair area.You are expected to live for more than 1 year.I have chosen to undergo surgery as my treatment option.I have a large aneurysm causing symptoms.My health is very poor, with major issues in two body systems.
Research Study Groups:
This trial has the following groups:- Group 1: Expanded Use Arm
- Group 2: Primary Study Arm
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 there availability for anyone to participate in this experiment?
"As made evident on clinicaltrials.gov, this medical trial is no longer enrolling patients; its initial post date was October 6th 2020 and the most recent edit was December 13th 2021. Yet, 152 other trials are currently enlisting participants at present time."
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