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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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19 October 2017 |
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Main ID: |
NCT02094300 |
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Date of registration:
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21/02/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Zenith® Dissection Endovascular System
STABLE I |
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Scientific title:
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Zenith® Dissection Endovascular System |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02094300 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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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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Inclusion Criteria:
- Branch vessel obstruction/compromise
- Peri-aortic effusion/hematoma
- Resistant hypertension
- Persistent pain/symptoms
- Transaortic growth >5 mm within 3 months
- Transaortic diameter >40 mm.
Exclusion Criteria:
- Age <18 years;
- Other medical condition (e.g., cancer, congestive heart failure) that may cause the
patient to be non-compliant with the protocol, 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 24 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.
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: Zenith® Dissection Endovascular Graft
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Primary Outcome(s)
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Number of Patients With Major Complications
[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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