Overview

This trial is active, not recruiting.

Condition aortic dissection involving the descending thoracic aorta
Treatments zenith® dissection endovascular system, endovascular repair
Sponsor William Cook Europe
Collaborator Cook
Start date December 2007
End date July 2011
Trial size 60 participants
Trial identifier NCT00526487, 07-004, 370010, TXD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Endovascular Repair
zenith® dissection endovascular system
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.
endovascular repair
Endovascular Repair

Primary Outcomes

Measure
The primary endpoint is survival at 30 days
time frame: 30 days

Secondary Outcomes

Measure
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Joseph Lombardi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Cook.