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Endovascular Repair
TEVAR + BMT for Aortic Dissection (ACUTE-B Trial)
N/A
Recruiting
Led By Kristofer M Charlton-Ouw, MD, FACS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has been stabilized after the acute event with control of pain and blood pressure using ≤3 intravenous antihypertensive medications
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
ACUTE-B Trial Summary
This trial is testing whether adding a Thoracic Endovascular Aortic Repair to Best Medical Therapy can improve outcomes for people with uncomplicated Acute Type B Aortic Dissection.
Who is the study for?
This trial is for adults over 18 with a recent (≤30 days old) uncomplicated acute type B aortic dissection, who've been stabilized and can follow the study plan. It's not for those with complicated cases, other health trials soon, severe kidney issues, recent major health events like heart attacks or strokes, pregnant/breastfeeding women, or certain genetic disorders.Check my eligibility
What is being tested?
The study compares two treatments for acute type B aortic dissection: standard best medical therapy (BMT) alone versus BMT combined with thoracic endovascular aortic repair (TEVAR). Participants will be randomly assigned to one of these treatment groups.See study design
What are the potential side effects?
Possible side effects from TEVAR may include bleeding at the access site, infection risk increase due to the procedure itself and potential complications related to device placement within the blood vessels.
ACUTE-B Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure and pain are under control with up to 3 IV medications.
ACUTE-B Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Secondary outcome measures
Any major morbidity events
Change in Quality of Life assessment
ACUTE-B Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BMT+TEVARExperimental Treatment1 Intervention
Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT)
Group II: BMT AloneActive Control1 Intervention
Patients in this group will be managed with the best medical therapy (BMT) alone
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,561 Total Patients Enrolled
3 Trials studying Aortic Dissection
6,226 Patients Enrolled for Aortic Dissection
Kristofer M Charlton-Ouw, MD, FACSPrincipal InvestigatorUniversity of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but I'm not familiar with the term "complicated ABAD." It seems to be a specific medical term or acronym that I'm not aware of. If you could provide more context or details, I'd be happy to help rewrite the criterion in simpler language.My anatomy is not suitable for a specific type of vascular surgery.I have not had a stroke in the last 3 months.You have an infection where the doctor needs to access your body for the study.You are not expected to live for more than 2 years.My aorta is enlarged, measuring 5.0 cm or more.My kidney function is reduced (stage 3-5).I have been diagnosed with Type A aortic dissection.I have had a Type B aortic dissection for more than 6 weeks.I can start the treatment as per the study's protocol within 30 days of my first symptoms.I was diagnosed with a specific type of aortic dissection within the last 30 days and it's not causing severe complications.My blood pressure and pain are under control with up to 3 IV medications.I haven't had major health issues like heart attacks or significant bleeding in the last 6 weeks.I am 18 years old or older.I have a condition like Marfan's syndrome or Ehlers-Danlos syndrome.I cannot or will not follow the study's follow-up requirements.I am currently fighting an infection in my body.I have been diagnosed with a traumatic dissection or penetrating ulcer.I have had surgery on my chest or belly aorta.
Research Study Groups:
This trial has the following groups:- Group 1: BMT+TEVAR
- Group 2: BMT Alone
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.
How many participants are contributing to this clinical trial?
"Affirmative. The clinical trial, which had its initial post date on October 1st 2018 is still enrolling patients according to information from clinicaltrials.gov . Currently the study requires 436 participants at 2 different venues."
Answered by AI
Is participation in this clinical experiment available to the public?
"The data available on clinicaltrials.gov affirms that this medical experiment is still recruiting participants, having been initially posted back in October of 2018 and most recently updated January 11th 2022."
Answered by AI
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