Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

Cook Group

Status

Conditions: Aortic Dissection

Treatments: Device: Endovascular Treatment (Zenith)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02464943

11-007-CA

Details and patient eligibility

About

The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• < 18 years of age
• 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., < 2 years)
• Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
• Unwilling to 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)