N/A
Completed N=73
Zenith® Dissection Clinical Trial
Source: ClinicalTrials.gov NCT01568320 ↗Enrolled (actual)
73
Serious AEs
86.3%
Results posted
Feb 2021
Primary outcomePrimary: Number of Participants With Freedom From Major Adverse Events — 48 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Freedom From Major Adverse Events |
48 | — |
| PRIMARY Survival Rate at 30 Days |
64 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01568320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.