Zenith® Dissection Endovascular System

Study Overview
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Brief Summary
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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.

Official Title
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Zenith® Dissection Endovascular System

Conditions
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Aortic Dissection

Intervention / Treatment
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* Device: Zenith® Dissection Endovascular Graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular<br> | Device: Zenith® Dissection Endovascular Graft<br>* 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.<br>* Other names: Stent-graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Major Complications | Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aorta, Thoracic, Aortic dissection, Rupture, Type B, DeBakey type III, Endovascular