Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection
- Conditions
- Aortic Dissection Involving the Descending Thoracic Aorta
- Registration Number
- NCT00526487
- Lead Sponsor
- William Cook Europe
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary endpoint is survival at 30 days 30 days
- Secondary Outcome Measures
Name Time Method Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity 12 months
Trial Locations
- Locations (8)
St. Vincent's Hospital Melbourne
🇦🇺Melbourne, Australia
St. Anne's Universtiy Hospital Brno
🇨🇿Brno, Czech Republic
CHRU de Lille
🇫🇷Lille, Cedex, France
Hannover Medical School
🇩🇪Hannover, Germany
Heart Center Leipzig / Park Hospital
🇩🇪Leipzig, Germany
Clinic of Internal Medicine, University Hospital Rostock
🇩🇪Rostock, Germany
Hospital San Raffaele
🇮🇹Milan, Italy
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
St. Vincent's Hospital Melbourne🇦🇺Melbourne, Australia