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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01568320 |
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Date of registration:
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29/03/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Zenith® Dissection Clinical Trial
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Scientific title:
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Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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73 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01568320 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Japan
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United States
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Contacts
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Name:
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Joseph Lombardi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cooper Health System |
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Key inclusion & exclusion criteria
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Exclusion Criteria:
1. Age < 18 years;
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aortic Dissection
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Intervention(s)
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Device: Endovascular Treatment (Zenith)
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Primary Outcome(s)
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Freedom from major adverse events
[Time Frame: 30 days]
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Survival rate
[Time Frame: 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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