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

N/AApproved For MarketingNCT02464943

Cook Research Incorporated

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Aortic Dissection

Interventions

Endovascular Treatment (Zenith)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Cooper University Hospital

Camden, New Jersey, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Data from ClinicalTrials.gov

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