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Stent Graft System
Valiant™Thoracoabdominal Stent Graft System for Aortic Aneurysm
N/A
Waitlist Available
Led By Thomas Maldonado
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to year 1
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether the ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System is safe and effective for the repair of thoracoabdominal aortic aneurysms.
Eligible Conditions
- Aortic Aneurysm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to year 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Freedom From Major Adverse Events (MAE) at Day 30
Number of Participants Who Achieve Technical Success
Secondary study objectives
Freedom From Paraplegia at Day 30
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Primary Arm: Treatment with Valiant Thoracoabdominal Stent Graft SystemExperimental Treatment1 Intervention
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Group II: Expanded Use Arm: Treatment with Valiant Thoracoabdominal Stent Graft SystemExperimental Treatment1 Intervention
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valiant™Thoracoabdominal Stent Graft System
2017
N/A
~20
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,739 Total Patients Enrolled
2 Trials studying Aortic Aneurysm
200 Patients Enrolled for Aortic Aneurysm
Thomas MaldonadoPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You can receive treatment using a medical device called an endovascular prosthesis, as long as it is approved and used according to the instructions provided.You have a tear or break in a specific area of your body.You have blocked or narrowed blood vessels that supply important organs in your body.You have significant problems with your heart, lungs, kidneys, liver, or muscles that affect how well your body functions.You have a type of chest pain called unstable angina that is getting worse or occurring at rest or during the night.You have an infection that could make it more likely for the graft in your blood vessels to become infected.You have a history of certain disorders that affect your connective tissues.Your blood vessels in the pelvis do not allow for the proper flow of blood to the lower body.Your left subclavian artery is blocked or narrow, which may prevent proper blood flow.You have a bulging blood vessel in your brain that is at high risk of bursting.The area where the stent graft needs to be placed in your body is too close to an important junction.There needs to be enough space around the celiac artery for inserting a tube during the procedure, taking into account the distance from the access point and the length of the surrounding structures.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Arm: Treatment with Valiant Thoracoabdominal Stent Graft System
- Group 2: Expanded Use Arm: Treatment with Valiant Thoracoabdominal Stent Graft System
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.
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