This trial is active, not recruiting.

Condition aortic dissection
Treatment endovascular treatment (zenith)
Sponsor Cook
Start date August 2012
End date April 2016
Trial size 73 participants
Trial identifier NCT01568320, 11-007


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Endovascular Treatment (Zenith)
endovascular treatment (zenith) Endovascular graft
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Primary Outcomes

Freedom from major adverse events and survival
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
Principal investigator Joseph Lombardi, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Cook.