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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
Sponsor:
Information provided by (Responsible Party):
Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston

Brief Summary:
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.

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

Detailed Description:

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:

  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Participant and investigator/treating physician would be blinded until the day of treament initiation
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: BMT Alone
Patients in this group will be managed with the best medical therapy (BMT) alone
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.

Experimental: BMT+TEVAR
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)
Other Names:
  • Medtronic® Valiant® Thoracic Stent Graft
  • Conformable GORE® TAG® Thoracic Endoprosthesis




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 5 years ]
    Participants would be followed for a period of 5 years following initial presentation


Secondary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Kristofer M Charlton-Ouw, MD, FACS University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
Publications:
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Responsible Party: Kristofer Charlton-Ouw, Associate Professor, Department of Cardiothoracic and Vascular Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02622542    
Other Study ID Numbers: CTVS-KC03
HSC-MS-15-0937 ( Other Identifier: University of Texas Health Science Center at Houston IRB )
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidentified data will be made available following IRB approval

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases