An interventional study of BMT+TEVAR and BMT in Distal Aortic Dissection, Dissection, Aortic Acute and Acute Type B Aortic Dissection (Uncomplicated), sponsored by The University of Texas Health Science Center, Houston. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
Study Design:
This is a prospective, two-arm, parallel-group, single-center, pragmatic, randomized clinical trial.
Population:
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.
Procedures:
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
Study Duration:
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.
Endpoints:
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.
385 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's planned enrollment of 436 is above the median of 84 across 198 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will be managed with the best medical therapy (BMT) alone
Other: BMT
Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT)
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)
Also known as: Medtronic® Valiant® Thoracic Stent Graft, Conformable GORE® TAG® Thoracic Endoprosthesis
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.
All-cause mortality
Participants would be followed for a period of 5 years following initial presentation
Time frame: 5 years
Any major morbidity events
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)
Time frame: 5 years
Change in Quality of Life assessment
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.
Time frame: 5 years
Plan to share: No — Deidentified data will be made available following IRB approval
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The University of Texas Health Science Center, Houston