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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 16
- Primary Endpoint
- The primary endpoint is survival at 30 days
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The primary endpoint is survival at 30 days
Time Frame: 30 days
Secondary Outcomes
- Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity(12 months)