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

Aortic Dissection Involving the Descending Thoracic Aorta Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526487
• Other study ID #: 07-004
• Secondary ID: 370010, TXD
• Status: Completed
• Phase: N/A
• First received: September 5, 2007
• Last updated: February 27, 2017
• Start date: December 2007
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection Involving the Descending Thoracic Aorta

Intervention

Device:
• 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

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Melbourne	Melbourne
Czech Republic	St. Anne's Universtiy Hospital Brno	Brno
France	CHRU de Lille	Lille	Cedex
Germany	Hannover Medical School	Hannover
Germany	Heart Center Leipzig / Park Hospital	Leipzig
Germany	Clinic of Internal Medicine, University Hospital Rostock	Rostock
Italy	Hospital San Raffaele	Milan
Italy	IRCCS Policlinico San Matteo	Pavia

Sponsors (4)

Lead Sponsor	Collaborator
William Cook Europe	Cook, MED Institute, Incorporated, William Cook Australia

Countries where clinical trial is conducted

Australia,  Czech Republic,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is survival at 30 days		30 days
Secondary	Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity		12 months