This trial is active, not recruiting.

Condition aortic dissection
Treatment zenith® dissection endovascular graft
Sponsor Cook
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

Study Design

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

Primary Outcomes

Percentage of patients with major adverse events
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Zenith® Dissection Endovascular System
Principal investigator Joseph Lombardi, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Cook.