Zenith® Dissection Clinical Trial
- Conditions
- Aortic Dissection
- Interventions
- Device: Endovascular Treatment (Zenith)
- Registration Number
- NCT01568320
- Lead Sponsor
- Cook Research Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endovascular Endovascular Treatment (Zenith) Endovascular Treatment (Zenith)
- Primary Outcome Measures
Name Time Method Survival Rate at 30 Days 30 days Primary effectiveness endpoint is freedom from all cause mortality at 30 days
Number of Participants With Freedom From Major Adverse Events 30 days 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, 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
University of Florida
🇺🇸Gainesville, 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
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
New York University Hospital
🇺🇸New York, New York, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Scott and White Hospital
🇺🇸Temple, Texas, United States
The Methodist Hospital
🇺🇸Houston, 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
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of South Florida
🇺🇸Tampa, Florida, United States