Study Results
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View full resultsBasic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2012-08-31
2020-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endovascular
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith)
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Interventions
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Endovascular Treatment (Zenith)
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
4. Unwilling or unable to comply with the follow-up schedule;
5. Inability or refusal to give informed consent;
6. Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);
7. Additional medical restrictions as specified in the Clinical Investigation Plan; or
8. Additional anatomical restrictions as specified in the Clinical Investigation Plan.
18 Years
ALL
No
Sponsors
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Cook Research Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Lombardi, MD
Role: PRINCIPAL_INVESTIGATOR
The Cooper Health System
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Indiana Heart Hospital
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York University Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The Methodist Hospital
Houston, Texas, United States
Scott and White Hospital
Temple, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
University of Washington-Harborview Medical Center
Seattle, Washington, United States
Jikei University School of Medicine
Tokyo, , Japan
Countries
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References
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Lombardi JV, Gleason TG, Panneton JM, Starnes BW, Dake MD, Haulon S, Mossop PJ, Seale MM, Zhou Q; STABLE II Investigators. STABLE II clinical trial on endovascular treatment of acute, complicated type B aortic dissection with a composite device design. J Vasc Surg. 2020 Apr;71(4):1077-1087.e2. doi: 10.1016/j.jvs.2019.06.189. Epub 2019 Aug 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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11-007
Identifier Type: -
Identifier Source: org_study_id
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