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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3HL165017-02 | U.S. NIH Grant/Contract | View source | |
| 5U24HL165029-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
| State University of New York - Downstate Medical Center | OTHER |
| Oregon Health and Science University | OTHER |
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The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.
The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upfront TEVAR plus Medical Therapy | Experimental | Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment). |
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| Medical Therapy with surveillance for deterioration | Active Comparator | Participants randomized to upfront Medical Therapy with Surveillance for Deterioration will be treated per routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEVAR | Procedure | Thoracic endovascular aortic repair |
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| Measure | Description | Time Frame |
|---|---|---|
| All-cause death or major aortic complications (MAC) | The primary endpoint is a composite of all-cause death or major aortic complications (MAC). MACs are defined as:
| Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol) | An adapted version of the AAAQol survey and the PROMIS-16 will be used to assess general and aortic specific quality of life. The AAAQol questionnaire was specifically developed and validated on patients with abdominal aortic aneurysms and measures both the physical and emotional impact of either 1) having an abdominal aortic aneurysm or 2) having surgical or endovascular therapy for an abdominal aortic aneurysm. This metric has been shown to be valid and responsive in abdominal aortic aneurysm. While it has not been tested in aortic dissection, its questions assess the same domains shown to be significantly impacted in patients with aortic dissection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Roebuck, M.S. | Contact | 919-316-0628 | megan.roebuck@duke.edu | |
| Kady-Ann Steen-Burrell, Ph.D. | Contact | 919-530-9711 | kady.ann.steen.burrell@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Manesh R Patel, M.D. | Duke University | Principal Investigator |
| Firas F Mussa, M.D. | The University of Texas at Houston | Principal Investigator |
| Panos Kougias, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
The Statistical and data analytic center (SDCC) will submit to the NHLBI data repository de-identified Limited Access Datasets (LADs) and associated documentation, for use by other investigators. The LADs and documentation will be submitted within 2 years after publication of the primary results manuscript. Documentation will include copies of the case report forms; a list of derived variables and the formulas used to create them; and a codebook providing for each variable the variable name, coding conventions, and distribution of values. It will also include a list of data modifications made when creating the LAD, and a copy of the informed consent template, so that future use of the data will be consistent with the consent provided by the study subjects.The goal is to make data available to other investigators while protecting the rights and privacy of the subjects who participated in the studies. The SDCC will anonymize the datasets.
2 years
The methods for restricting access will also need to be determined, either with password access and/or with executed Data Agreements. Related to the restricted use of data is the need to specify appropriately in informed consent forms that the study participant's de-identified data may be made available to other researchers.
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| National Heart, Lung, and Blood Institute (NHLBI) |
| NIH |
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| Guideline directed medical therapy and surveillance of dissection |
| Other |
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines. |
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| Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Cumulative incidence of cardiovascular (CV) hospitalizations | CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Mean number of cardiovascular (CV) hospitalizations | CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of cardiovascular death | Death from any cardiovascular cause. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of all-cause death | Death from any case | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Cumulative incidence of major aortic complications (MAC) | Composite endpoint. MACs are defined as: • Aortic rupture • Malperfusion syndrome • New aortic tear requiring intervention, • Retrograde aortic dissection, • Dependence on outpatient dialysis (chronic) • Major amputation (above ankle) • Tracheostomy • fistula formation (e.g., aorto-esophageal, aorto-tracheal) • Spinal Cord Ischemia with paralysis or paresis • Stroke • AD-related intervention in either group defined as: - Open TAA/TAAA Repair - Fenestrated and/or Branched Endovascular Repair of TAAA - Repeat TEVAR | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of stroke | Defined as a focal neurological deficit that could be attributed to a vascular territory and lasted >24 hours or was associated with a new lesion on computed tomography scan or magnetic resonance imaging. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of paraplegia or paraparesis | Defined as including: 1) flaccid paraplegia (no lower extremity movement), or lower extremity movement without gravity, or lower extremity movement with gravity, or standing with assistance or walking with assistance. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of vascular access injury requiring surgical repair | Defined as any open surgical procedure to treat a vascular injury at the site of vascular access for a previous endovascular procedure. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of aortobronchial / aortoesophageal fistula | Defined as fistulous connection between the aorta and bronchus as confirmed by chest imaging or direct visualization (surgical or bronchoscopic). Aortoesophageal fistula is defined as a fistulous connection between the aorta and the esophagus as confirmed by chest imaging or direct visualization (surgical or endoscopically). | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of retrograde type A dissection | Defined as any new ascending arch, or descending dissection contiguous with and proximal to the original presenting anatomy as confirmed by imaging. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of aortic-related death | Aortic-related death will be defined as death within 30 days of 1) diagnosis of aortic dissection 2) any aortic intervention or 3) ruptured aortic aneurysm. | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Number of days alive and out of the hospital | Defined as the number of days alive minus the number of days in the hospital over 4 years (primary analysis). | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| Incidence of secondary percutaneous interventions after TEVAR | Any secondary percutaneous intervention after TEVAR | Last follow-up timepoint. Differential follow-up with median of about 4 years |
| The State University of New York at Downstate |
| Principal Investigator |
| Sreekanth Vemulapalli, M.D. | Duke University | Principal Investigator |
| Sean O'Brien, Ph.D. | Duke University | Principal Investigator |
| Honorhealth | Recruiting | Phoenix | Arizona | 85020 | United States |
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| Memorial Care Long Beach Medical Center | Recruiting | Long Beach | California | 90806 | United States |
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| Keck Medical Center of USC | Recruiting | Los Angeles | California | 90033 | United States |
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| University of California San Diego | Withdrawn | San Diego | California | 92110 | United States |
| University of California | Recruiting | San Francisco | California | 94143 | United States |
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| Stanford University Medical Center | Withdrawn | Stanford | California | 94305 | United States |
| University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States |
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| Memorial Hospital Central | Recruiting | Colorado Springs | Colorado | 90803 | United States |
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| Hartford Hospital | Recruiting | Hartford | Connecticut | 06102 | United States |
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| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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| University of Florida Health | Recruiting | Gainesville | Florida | 32608 | United States |
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| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| The University of Chicago | Withdrawn | Chicago | Illinois | 60637 | United States |
| Southern Illinois University School of Medicine | Recruiting | Springfield | Illinois | 62702 | United States |
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| Indiana University Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| MaineHealth | Recruiting | Scarborough | Maine | 04101 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21230 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| University of Massachusetts Memorial | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| University of Michigan Health | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
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| Spectrum Health and Hospitals and Corewell | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Mayo Clinic | Withdrawn | Rochester | Minnesota | 55905 | United States |
| University of Missouri Health Care | Recruiting | Columbia | Missouri | 65212 | United States |
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| Washington University School of Medicine | Withdrawn | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Withdrawn | Omaha | Nebraska | 68198 | United States |
| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
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| Rutgers UH Vascular Center | Recruiting | Jersey City | New Jersey | 07302 | United States |
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| Maimonides Medical Center | Withdrawn | Brooklyn | New York | 11219 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
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| St. Francis Hospital and Heart Center | Recruiting | Roslyn | New York | 11576 | United States |
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| Stony Brook University Medical Center | Recruiting | Stony Brook | New York | 11794 | United States |
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| SUNY Upstate Medical University | Recruiting | Syracuse | New York | 13120 | United States |
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| University of North Carolina Chapel Hill | Withdrawn | Chapel Hill | North Carolina | 27599 | United States |
| Sanger Heart & Vascular Institute | Withdrawn | Charlotte | North Carolina | 28201 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Harrington Heart and Vascular Institute | Recruiting | Cleveland | Ohio | 44106 | United States |
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| The Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| UT Dell Medical School- Ascension | Recruiting | Austin | Texas | 78712 | United States |
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| Baylor Scott & White Research Institute | Recruiting | Dallas | Texas | 75226 | United States |
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| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| The University of Texas Health Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Baylor Scott & White The Heart Hospital - Plano | Recruiting | Plano | Texas | 75093 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| Sentara Cardiovascular Research Institute | Recruiting | Norfolk | Virginia | 23507 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
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| CAMC Clinical Trials Center | Recruiting | Charleston | West Virginia | 25304 | United States |
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| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| CHUM - Centre hospitalier de l'Universite de Montreal | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
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| McGill University Medical Center | Recruiting | Montreal | Quebec | H3A 0G4 | Canada |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
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