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Stent-Graft System
Thoracic Stent-Graft for Aortic Aneurysm (RelayBranch Trial)
N/A
Waitlist Available
Led By Wilson Szeto, MD
Research Sponsored by Bolton Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anatomy that would require coverage of the brachiocephalic trunk (BCT) and/or left carotid arteries if a non-branch endograft were implanted
Non-aneurysmal BCT and left common carotid arteries with specific diameter requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above
Awards & highlights
RelayBranch Trial Summary
This trial is looking at the safety and effectiveness of a new device that will be used to treat aortic pathologies. The device will be delivered and deployed during the index procedure, and patency of branches and branch vessels will be assessed at 30-day follow-up.
Who is the study for?
This trial is for adults with specific types of aortic aneurysms or penetrating ulcers in the ascending aorta, arch, or proximal descending thoracic aorta. Candidates must have anatomy suitable for the stent-graft system and be willing to follow up after treatment. Exclusions include severe allergies to device materials, certain heart and lung conditions, recent major procedures, systemic infections, renal failure, and other investigational study involvement.Check my eligibility
What is being tested?
The RelayBranch Thoracic Stent-Graft System is being tested for safety and effectiveness in treating thoracic aortic aneurysms. The trial involves implanting this device into patients' affected arteries and monitoring them closely at initial deployment and again after 30 days to assess how well it works.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications related to the stent-graft such as blood vessel damage during insertion, movement of the graft post-surgery (migration), blockage (occlusion), infection risk from surgery or device-related issues.
RelayBranch Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My treatment would involve covering key arteries near my heart with a graft.
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My blood vessels in the neck meet the required size criteria.
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I have a type B aortic dissection that is stable and not causing complications.
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I have an abnormal bulge in the upper part of my aorta.
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I have an aneurysm in the upper part of my aorta.
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My aorta's upper and lower ends meet the specific size requirements.
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I am at high risk for surgery due to my health condition.
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My condition has not improved despite receiving the best available treatment.
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I am 18 years old or older.
RelayBranch Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of Major Adverse Events (MAEs)
Secondary outcome measures
Composite of the following Criteria
RelayBranch Trial Design
1Treatment groups
Experimental Treatment
Group I: Relay Branch SystemExperimental Treatment1 Intervention
Subjects who receive the Relay Branch System for repair which includes those with aneurysmal disease, penetrating atherosclerotic ulcer (PAU), and chronic uncomplicated Type B aortic dissection.
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Who is running the clinical trial?
Bolton MedicalLead Sponsor
15 Previous Clinical Trials
2,586 Total Patients Enrolled
Wilson Szeto, MDPrincipal InvestigatorPenn Presbyterian Medical Center
3 Previous Clinical Trials
203 Total Patients Enrolled
Luis Sanchez, MDPrincipal InvestigatorBarnes Jewish Hospital, Washington Univ
3 Previous Clinical Trials
834 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The area where the graft needs to be placed is too close to important blood vessels.I am on blood thinners for a heart rhythm problem or a clotting disorder.My blood pressure and heart rate are unstable.I have a connective tissue disorder, mycotic aneurysm, or infected aorta.My treatment would involve covering key arteries near my heart with a graft.You had a mechanical aortic valve replaced, except if it's a special type with biological leaflets.There are specific rules for where the graft attaches to the arch of the blood vessel.My aorta's curve near the heart is less than 15mm.Both of my subclavian arteries will be blocked or covered before a procedure.My blood flow in both vertebral arteries might be affected by a stent placement.Your blood vessels need to be a certain size and length for the study.There are certain requirements for where the stent will be placed in the blood vessel.I need surgery for an aneurysm or disease in my abdominal aorta.I have severe heart failure (NYHA class IV).I have not had a heart attack in the last 3 months.I have had a procedure to repair my thoracic aorta.My treatment may cover the left subclavian artery, with plans for revascularization if needed.My blood vessels in the neck meet the required size criteria.My arteries are suitable for a specific medical device insertion.I have a major blockage in my carotid artery.I cannot stop my blood disorder treatment for a week before and after surgery.I had surgery for an abdominal aortic aneurysm less than 6 months ago.I have a type B aortic dissection that is stable and not causing complications.I haven't had major surgery in the last 45 days and don't plan any in the next 60 days.My blood vessels at certain sites are narrowed, hardened, or twisted.I am currently experiencing sudden kidney failure.I have severe lung disease.I do not have an active infection.I have an abnormal bulge in the upper part of my aorta.You are not expected to live for more than two years.I have been diagnosed with a type of heart condition known as Acute Coronary Syndrome.I have not had a stroke in the last year.You have a severe allergy to the contrast dye or any parts of the medical device.You are very overweight or have a health condition that makes it difficult to get the necessary imaging tests.I have an aneurysm in the upper part of my aorta.My aorta's upper and lower ends meet the specific size requirements.I am at high risk for surgery due to my health condition.My condition has not improved despite receiving the best available treatment.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Relay Branch 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.
What is the participation rate for this research endeavor?
"To meet the requirements of this medical trial, 40 qualified patients are being sought. The University of Florida in Gainesville and Baylor College of Medicine in Houston have been identified as two potential enrolment sites."
Answered by AI
How many hospital facilities are managing this clinical trial?
"This clinical trial is currently enrolling patients at the University of Florida in Gainesville, as well as Baylor College of Medicine and Baylor Scott & White Research Institute located in Houston and Plano respectively. Additionally, there are 10 other sites offering enrollment opportunities."
Answered by AI
Are there any new participants being admitted into this research project?
"Clinicaltrials.gov lists this trial as an active recruitment effort, with the first posting occuring on December 4th 2017 and a recent update happening on July 26th 2022."
Answered by AI
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