ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy (ACUTE-B)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02622542|
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Distal Aortic Dissection Dissection, Aortic Acute Acute Type B Aortic Dissection (Uncomplicated)||Device: BMT+TEVAR Other: BMT||Not Applicable|
This is a prospective, two-arm, parallel-group, single-center, pragmatic, randomized clinical trial.
The target population comprises all adult patients aged 18 years and older who present with uncomplicated acute type B aortic dissection. The study sample will include 436 subjects of both genders and any race or ethnicity.
Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms: BMT vs BMT+TEVAR
The study is expected to accrue patients over the course of 5 years and total follow up per patient for 5 years. Overall duration of the study is anticipated to be about 10 years for completion of all study endpoints.
- Primary Outcome: To determine all-cause mortality among both study arms.
- Secondary Outcomes: To assess any major morbidity events (rupture, aortic intervention or reintervention, progression to complicated dissection, aneurysm formation, malperfusion resulting in organ failure, and aorta-specific mortality), as will quality of life measures, temporal discounting assessment and outcomes comparison in an observational cohort of patients who decline to be randomized due to a strong treatment preference.
Risks and Benefits:
Since this study involves only usual care and FDA-approved treatments, the investigators do not expect any additional physical risks to patients beyond those associated with usual care. One discernible risk involved in study participants is an unintentional disclosure of sensitive patient health information.
The participants of this study do not stand to benefit directly from taking part. However, the investigators hope that the results obtained from this study would provide useful information that would help delineate a standard and economical management protocol for acute Type B aortic dissection in future.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||436 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Participant and investigator/treating physician would be blinded until the day of treament initiation|
|Official Title:||A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2028|
Active Comparator: BMT Alone
Patients in this group will be managed with the best medical therapy (BMT) alone
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.
Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT)
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)
- All-cause mortality [ Time Frame: 5 years ]Participants would be followed for a period of 5 years following initial presentation
- Any major morbidity events [ Time Frame: 5 years ]Participants would be followed for a period of 5 years following initial presentation to record any major events (rupture, aortic intervention or reintervention, progression to complicated dissection, aneurysm formation, malperfusion resulting in organ failure, and aorta-specific mortality)
- Change in Quality of Life assessment [ Time Frame: 5 years ]Participants would be followed for a period of 5 years following initial presentation to assess the change in their quality of life as compared to baseline or prior to disease onset by using Aortic Disease Quality of Life (ADQoL) instrument and the validated general health related quality of life instrument called Short Form -12 (SF-12). The ADQoL is an instrument that measures the quality of life in 5 major domains - physical limitations, social limitations, general health perceptions, emotional limitations, and aortic-disease specific limitations. Lower scores on individual subscales and overall are deemed to be poor quality of life and higher scores indicate good quality of life. the SF-12 is also designed to assess general health related quality of life and is also scored and assessed similarly, i.e, higher scores indicate good general health related quality of life and measures health perception, physical, emotional, and social limitations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622542
|Contact: Harleen K Sandhu, MD, MPH||7134865131||Harleen.K.Sandhu@uth.tmc.edu|
|Contact: Kristofer M Charlton-Ouw, MD, FACS||713-486-5100||Kristofer.CharltonOuw@uth.tmc.edu|
|United States, Texas|
|Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Kristofer M Charlton-Ouw, MD 713-486-5100 Kristofer.CharltonOuw@uth.tmc.edu|
|Contact: Harleen K Sandhu, MD 713-486-5131 Harleen.K.Sandhu@uth.tmc.edu|
|Principal Investigator: Kristofer M Charlton-Ouw, MD|
|Sub-Investigator: Harleen K Sandhu, MD, MPH|
|Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast||Recruiting|
|Houston, Texas, United States, 77089|
|Contact: Gordon Martin, MD 713-486-1160|
|Contact: Naveed Saqib, MD 713-486-1160|
|Sub-Investigator: Gordon Martin, MD|
|Sub-Investigator: Naveed Saqib, MD|
|Principal Investigator:||Kristofer M Charlton-Ouw, MD, FACS||University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston|