Zenith® Dissection Endovascular System
This trial is active, not recruiting.
|Treatment||zenith® dissection endovascular graft|
|Start date||December 2007|
|End date||February 2012|
|Trial size||26 participants|
|Trial identifier||NCT02094300, 05-622|
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 patients with aortic dissection.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Gainesville, FL||University of Florida||no longer recruiting|
|Boston,, MA||Massachusetss General Hospital||no longer recruiting|
|Camden, NJ||Cooper University Hospital||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Philadephia, PA||Thomas Jefferson University Hospital||no longer recruiting|
|Intervention model||single group assignment|
Percentage of patients with major adverse events
time frame: 30 days
Male or female participants at least 18 years old.
- Branch vessel obstruction/compromise
- Peri-aortic effusion/hematoma
- Resistant hypertension
- Persistent pain/symptoms
- Transaortic growth >5 mm within 3 months
- Transaortic diameter >40 mm.
- 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.
|Official title||Zenith® Dissection Endovascular System|
|Principal investigator||Joseph Lombardi, MD|
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