Distal Aortic DissectionACUTE-BNCT02622542
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
A study testing BMT+TEVAR and BMT in people with Distal Aortic Dissection and Dissection, Aortic Acute, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Aortic Dissection, Dissection, Aortic Acute, Acute Type B Aortic Dissection (Uncomplicated)
- What is being tested?
- BMT+TEVAR and BMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2018to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Houston, Texas, 77030
Harleen K Sandhu, MD, MPH, 713-486-5100, harleen.k.sandhu@uth.tmc.edu
Kristofer M Charlton-Ouw, MD, 713-486-5100, Kristofer.CharltonOuw@uth.tmc.edu
- Recruiting
Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
Houston, Texas, 77089
Gordon Martin, MD, 713-486-1160
Naveed Saqib, MD, 713-486-1160
About this study
Official title: A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection
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.
Read the 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.
- Conditions
- Distal Aortic Dissection, Dissection, Aortic Acute, Acute Type B Aortic Dissection (Uncomplicated)
- Being tested
- BMT+TEVAR, BMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT+TEVARDevice
Also called Medtronic® Valiant® Thoracic Stent Graft, Conformable GORE® TAG® Thoracic Endoprosthesis
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)
BMTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BMT Alone | Active comparator | Patients in this group will be managed with the best medical therapy (BMT) alone Receives: Other: BMT |
| BMT+TEVAR | Experimental | Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT) Receives: Device: BMT+TEVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Participants would be followed for a period of 5 years following initial presentation
Measured: 5 years
Secondary outcomes (2)
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)
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start1 Oct 2018
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Distal Aortic DissectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harleen K Sandhu, The University of Texas Health Science Center, Houston
- Investigators
- Kristofer M Charlton-Ouw, MD, FACS, Principal investigator, University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622542
- Sponsor's protocol ID
- CTVS-KC03
- Other IDs
- HSC-MS-15-0937
- Acronym
- ACUTE-B
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2015
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Deidentified data will be made available following IRB approval
Publications
Afifi RO, Sandhu HK, Leake SS, Boutrous ML, Kumar V 3rd, Azizzadeh A, Charlton-Ouw KM, Saqib NU, Nguyen TC, Miller CC 3rd, Safi HJ, Estrera AL. Outcomes of Patients With Acute Type B (DeBakey III) Aortic Dissection: A 13-Year, Single-Center Experience. Circulation. 2015 Aug 25;132(8):748-54. doi: 10.1161/CIRCULATIONAHA.115.015302.
PubMed 26304666Nienaber CA, Rousseau H, Eggebrecht H, Kische S, Fattori R, Rehders TC, Kundt G, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Ince H; INSTEAD Trial. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation. 2009 Dec 22;120(25):2519-28. doi: 10.1161/CIRCULATIONAHA.109.886408. Epub 2009 Dec 7.
PubMed 19996018Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.
PubMed 23922146
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT02622542
- Acronym / sponsor ID
- ACUTE-B / CTVS-KC03
- Conditions
- Distal Aortic Dissection, Dissection, Aortic Acute, Acute Type B Aortic Dissection (Uncomplicated)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMT Alone | Active comparator | Other: BMTPatients in this group will be managed with the best medical therapy (BMT) alone |
| BMT+TEVAR | Experimental | Device: BMT+TEVARPatients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMT+TEVARAlso: Medtronic® Valiant® Thoracic Stent Graft, Conformable GORE® TAG® Thoracic EndoprosthesisThese 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) | Device | BMT+TEVAR |
| BMTOptimal 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. | Other | BMT Alone |
Primary outcome
All-cause mortality
Time frame: 5 years
Participants would be followed for a period of 5 years following initial presentation
2 secondary outcomes
Any major morbidity events
Time frame: 5 years
Change in Quality of Life assessment
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Background: PubMed 26304666Afifi RO, Sandhu HK, Leake SS, Boutrous ML, Kumar V 3rd, Azizzadeh A, Charlton-Ouw KM, Saqib NU, Nguyen TC, Miller CC 3rd, Safi HJ, Estrera AL. Outcomes of Patients With Acute Type B (DeBakey III) Aortic Dissection: A 13-Year, Single-Center Experience. Circulation. 2015 Aug 25;132(8):748-54. doi: 10.1161/CIRCULATIONAHA.115.015302.
- Background: PubMed 19996018Nienaber CA, Rousseau H, Eggebrecht H, Kische S, Fattori R, Rehders TC, Kundt G, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Ince H; INSTEAD Trial. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation. 2009 Dec 22;120(25):2519-28. doi: 10.1161/CIRCULATIONAHA.109.886408. Epub 2009 Dec 7.
- Background: PubMed 23922146Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.
- Individual participant dataSharing planned: No. Deidentified data will be made available following IRB approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristofer M Charlton-Ouw, MD, FACS principal investigator
University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMT+TEVAR and BMT in people with Distal Aortic Dissection and Dissection, Aortic Acute, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harleen K Sandhu, MD, MPH (7134865131, Harleen.K.Sandhu@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622542, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.