Zenith® Dissection Clinical Trial
Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
1 other identifier
interventional
73
2 countries
24
Brief Summary
The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2020
CompletedResults Posted
Study results publicly available
February 16, 2021
CompletedMarch 16, 2021
February 1, 2021
2.5 years
March 29, 2012
January 29, 2021
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Freedom From Major Adverse Events
Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
30 days
Survival Rate at 30 Days
Primary effectiveness endpoint is freedom from all cause mortality at 30 days
30 days
Study Arms (1)
Endovascular
EXPERIMENTALEndovascular Treatment (Zenith)
Interventions
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.
Eligibility Criteria
You may not qualify if:
- Age \< 18 years;
- 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);
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
- Unwilling or unable to comply with the follow-up schedule;
- Inability or refusal to give informed consent;
- 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.);
- Additional medical restrictions as specified in the Clinical Investigation Plan; or
- Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Florida
Gainesville, Florida, 32610, United States
University of South Florida
Tampa, Florida, 33606, United States
Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New York University Hospital
New York, New York, 10016, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Scott and White Hospital
Temple, Texas, 76508, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Sentara Vascular Specialists
Norfolk, Virginia, 23507, United States
University of Washington-Harborview Medical Center
Seattle, Washington, 98104, United States
Jikei University School of Medicine
Tokyo, Japan
Related Publications (1)
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.
PMID: 31477479DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Saunders, MS, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Lombardi, MD
The Cooper Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 29, 2012
First Posted
April 2, 2012
Study Start
August 1, 2012
Primary Completion
February 1, 2015
Study Completion
January 27, 2020
Last Updated
March 16, 2021
Results First Posted
February 16, 2021
Record last verified: 2021-02