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Stent-Graft
RelayPro Stent-Graft for Aortic Dissection
N/A
Waitlist Available
Led By Ed Y Woo, 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 an acute (symptom onset to diagnosis within 2 weeks) or subacute, complicated type B aortic dissection confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with malperfusion of the viscera, kidneys, spinal cord, or lower extremities, rupture, or intractable pain
Proximal and distal aortic neck with diameter between 19 mm and 42 mm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 6, and 12 month follow-up visits, and annually through 5 years.
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of the RelayPro thoracic endograft in treating people with aortic dissection.
Who is the study for?
This trial is for individuals with a recent (within 6 weeks) and severe type B aortic dissection, confirmed by imaging tests. Participants must have specific complications like organ malperfusion or rupture, suitable vascular access for the device, and an anatomy that fits the stent-graft requirements. Exclusions include prior major surgeries in affected areas, unstable heart conditions, severe lung disease requiring oxygen therapy, acute kidney failure not on dialysis, extreme obesity affecting imaging quality, among others.Check my eligibility
What is being tested?
The RelayPro Thoracic Stent-Graft system is being tested in patients with acute complicated type B aortic dissection. The study is prospective and non-randomized to evaluate if this stent can effectively treat the condition while monitoring all-cause mortality within 30 days after the procedure.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of stent-grafts may include bleeding at the entry site; movement or misplacement of the stent; injury to blood vessels; blood clots; infection; allergic reactions to materials used in the graft.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My aortic dissection was diagnosed within 6 weeks of symptom onset and is causing severe complications.
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The diameter of my aortic neck is between 19 mm and 42 mm.
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My arteries are suitable for a specific medical device insertion.
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My body's structure fits the specific requirements for the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 6, and 12 month follow-up visits, and annually through 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6, and 12 month follow-up visits, 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
All-cause mortality post-procedure
Secondary outcome measures
Tissue Dissection
Technical Success at the time of the index procedure
Treatment success through 1 month
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: Relay ProExperimental Treatment1 Intervention
The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.
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Who is running the clinical trial?
Bolton MedicalLead Sponsor
15 Previous Clinical Trials
2,560 Total Patients Enrolled
4 Trials studying Aortic Dissection
354 Patients Enrolled for Aortic Dissection
Ed Y Woo, MDPrincipal InvestigatorMedStar Regional Vascular Program.
Christian Shults, MDPrincipal InvestigatorMedstar Washington Hospital Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke or heart attack in the last 3 months.I have had a traumatic injury to the main artery in my chest.My blood vessels are not suitable for certain medical device placements.You have a severe allergy to contrast dye or metal stents that cannot be treated.My aortic dissection was diagnosed within 6 weeks of symptom onset and is causing severe complications.The diameter of my aortic neck is between 19 mm and 42 mm.You have a known or suspected condition that affects your connective tissues.You are very sick and not expected to live for another day, with or without an operation.I have a bleeding or clotting disorder that can't be paused for surgery.I have severe heart failure (NYHA class IV).I had surgery for an abdominal aortic aneurysm less than 6 months ago.I haven't had or planned major surgery 30 days before or after the procedure.You are very overweight or have a condition that could make it difficult to get the needed imaging tests.I have had surgery or a procedure on the main artery in my chest.I need daily oxygen therapy at home.I have kidney problems but am not on dialysis.My blood pressure and heart rate are not stable.My arteries are suitable for a specific medical device insertion.I need surgery for an aneurysm in my aorta.You are expected to live for less than two years.My body's structure fits the specific requirements for the treatment.I have an ongoing infection or fungal aneurysm.I have had dead bowel tissue.I have unstable chest pain due to heart disease.My treatment plan may affect blood flow to major arteries in my neck or stomach area.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Relay Pro
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 available slots in this trial for participants?
"Per the clinicaltrials.gov, this trial is not open to new enrollees at present. This research was initially posted on December 14th 2017 and most recently updated July 25th 2022; however, there are still 52 other ongoing trials that are actively recruiting patients."
Answered by AI
How widely is this experiment being carried out in Canadian health care facilities?
"This medical experiment is now recruiting from 33 different clinics. Portland, Ann Arbor, and Long Beach are included in the list of eligible sites; several other cities are also available to potential participants. To reduce travel needs, it's advised that individuals select a site closest to them when applying."
Answered by AI
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