NCT02622542 · The University of Texas Health Science Center, Houston
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
(ACUTE-B)
What this study is about
The purpose of the study is to conduct a randomly assigned controlled trial comparing best medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for uncomplicated acute type B aortic dissection.
View original scientific description
The purpose of the study is to conduct a randomized controlled trial comparing best medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for uncomplicated acute type B aortic dissection.
Interventions
DEVICE
BMT+TEVAR
These FDA-approved devices will be used for performing TEVAR in the patients randomized to this arm, in addition to the medical therapy to control blood pressure (BMT)
OTHER
BMT
Optimal medical therapy will be administered to the patients randomized to this arm, involving but not limited to, beta-blockers, etc., to control the blood pressure and pain for stabilizing the patient upon presentation.
Primary outcome measures
All-cause mortality
Time frame: 5 years
Participants would be followed for a period of 5 years following initial presentation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged ≥18 years, regardless of race or ethnicity;
- Diagnosed with uncomplicated ABAD, i.e., a primary entry tear distal to left subclavian artery with no evidence of malperfusion, end-organ ischemia, rupture, or intractable pain, and onset of symptoms is ≤30 days prior to enrollment;
- Patient has been stabilized after the acute event with control of pain and blood pressure using ≤3 intravenous antihypertensive medications;
- Adequate imaging, e.g., CT with contrast (chest + abdomen+ pelvis) is available prior to enrollment; and
- Indicates willingness to comply with the study protocol and is able to provide a written informed consent;
- Meets criteria for inclusion in the National Death Index and Social Security Death Master File.
Exclusion criteria
- Diagnosed with Type A aortic dissection;
- Evidence of complicated ABAD;
- Chronic Type B aortic dissection (\>6 weeks from onset of symptoms);
- Unable to be randomized and undergo treatment according to protocol within 30 days of symptom onset;
- Diagnosed with traumatic dissection or penetrating ulcer;
- Anatomy is not suitable for TEVAR;
- Previous descending thoracic or abdominal aortic surgery (open or endovascular);
- Unsuitable access sites, including infection at access sites;
- Associated aortic aneurysm (descending aortic diameter ≥5.0 cm);
- Life expectancy \<2 years;
- Unable or unlikely to comply with BMT;
- Unable or refuse to comply with follow-up;
- Intend to participate in another trial within 3 months of enrollment;
- Pregnant or breast-feeding;
- Vasculitis or known genetic connective tissue disorder (Marfan's syndrome or Ehlers-Danlos syndrome)
- Active systemic infection;
- Chronic kidney disease stage 3-5 (estimated glomerular filtration rate \<60 mL/min/1.73m2);
- Cerebral vascular accident within past 3 months; or
- Clinically significant gastrointestinal bleeding, major surgery, myocardial infarction, or untreated coagulopathy within past 6 weeks.
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2022 · Source of record for eligibility and locations