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Stent-Graft
Thoracic Stent-Graft for Thoracic Aortic Injury
N/A
Waitlist Available
Led By Ben Starnes, MD
Research Sponsored by Bolton Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery
Age greater than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 months, 12 months, and annually through 5 years
Awards & highlights
Study Summary
This trial is looking at the safety and effectiveness of a new device to treat people who have suffered a traumatic injury to their descending thoracic aorta.
Who is the study for?
This trial is for adults over 18 with a recent traumatic injury to the descending thoracic aorta. Candidates must have specific aortic dimensions, be willing to follow up, and consent to treatment. Exclusions include severe artery issues, other major heart or lung conditions, allergies to device materials, recent stroke or heart attack, chronic kidney failure not on dialysis, life expectancy under two years, certain anatomical variants affecting blood flow after device placement.Check my eligibility
What is being tested?
The study tests the Relay Pro Thoracic Stent-Graft System's safety and effectiveness in repairing traumatic injuries of the descending thoracic aorta. Participants will receive this stent-graft system and their recovery and outcomes will be monitored.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include complications at insertion sites such as bleeding or infection; allergic reactions; migration of the stent; damage to surrounding vessels or tissues; clotting issues leading to stroke or limb ischemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My aorta's affected area is between my neck artery and the artery to my stomach.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month, 6 months, 12 months, and annually through 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 6 months, 12 months, and annually through 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mortality post-procedure
Secondary outcome measures
All-cause mortality
Aortic expansion
Aortic rupture
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Relay Pro Thoracic Stent-Graft SystemExperimental Treatment1 Intervention
The Relay Pro arm includes subjects who receive the device to treat traumatic injury of the descending thoracic aorta with the RelayPro Thoracic Stent-Graft System
Find a Location
Who is running the clinical trial?
Bolton MedicalLead Sponsor
15 Previous Clinical Trials
2,566 Total Patients Enrolled
Ben Starnes, MDPrincipal InvestigatorUniversity of Washington
Ravi Rajani, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very serious injury.My aorta's affected area is between my neck artery and the artery to my stomach.I need surgery for an aneurysm in my chest or abdomen.I have a bleeding or clotting disorder that can't be paused for surgery.I have severe heart failure.I have not had a stroke or heart attack in the last 3 months.I am older than 18 years.My blood vessels at the intended device site are not suitable for a secure device placement.You have a known or suspected condition that affects your connective tissues.My blood pressure and heart rate are not stable.My treatment involves covering arteries in my neck or abdomen that cannot be fixed with surgery.I had a traumatic injury to my chest's main artery less than 30 days ago.My arteries are suitable for a specific medical device insertion.I need daily oxygen therapy at home.I have an ongoing infection or fungal aneurysm.You are extremely overweight or have another condition that may make it difficult to take the required pictures of your body.I have had surgery or a procedure in my descending thoracic aorta without any grafts placed.I have unstable chest pain due to heart disease.You are expected to live for less than two more years.I have kidney problems but am not on dialysis.The area where the device will be placed is between 19 mm and 42 mm in diameter.You have a severe allergy or sensitivity to contrast dye or the materials used in the device.
Research Study Groups:
This trial has the following groups:- Group 1: Relay Pro Thoracic 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for prospective participants in this trial?
"Unfortunately, the clinicaltrials.gov posting for this trial indicates that it is no longer actively looking for participants; the study was initially posted in April 2017 and most recently edited on May 13th 2022. However, there are currently 791 other trials open to enrollment across the world."
Answered by AI
In what locations is this medical experiment taking place?
"This medical trial has 16 available locations, including Beth Israel Deaconess Medical Center / Harvard Medical School in Boston and St. Louis University in Saint Louis. There are also 14 additional sites for prospective participants to consider."
Answered by AI
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