Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

Detailed Description
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The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Official Title
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Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

Conditions
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Aortic Dissection Involving the Descending Thoracic Aorta

Intervention / Treatment
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* Device: Zenith® Dissection Endovascular System
* Device: Endovascular Repair


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 greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm) Exclusion Criteria: Age less than 18 years Frank rupture Diagnosed or suspected congenital degenerative connective tissue disease Systemic infection Untreatable reaction to contrast Surgical/endovascular AAA repair within 30 days Previous placement of thoracic endovascular graft Prior repair of descending thoracic aorta Interventional/open procedures within 30 days Onset of symptoms > 3 months

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Endovascular Repair | Device: Zenith® Dissection Endovascular System<br>* The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.<br>Device: Endovascular Repair<br>* Endovascular Repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is survival at 30 days |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Dissection, Dissection, Endovascular