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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Cook

MED Institute, Incorporated

William Cook Australia

Information provided by (Responsible Party):

Cook ( William Cook Europe )

ClinicalTrials.gov Identifier:

NCT00526487

First received: September 5, 2007

Last updated: December 21, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 5, 2007

Last Updated Date

December 21, 2012

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is survival at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

The primary endpoint is survival at 30 days

Change History

Complete list of historical versions of study NCT00526487 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity [ Time Frame: 12 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Aortic Dissection Involving the Descending Thoracic Aorta

Intervention ^ICMJE

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.
Device: Endovascular Repair
Endovascular Repair

Study Arm (s)

Endovascular Repair

Interventions:

Device: Zenith® Dissection Endovascular System
Device: Endovascular Repair

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2016

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Czech Republic, France, Germany, Italy

Administrative Information

NCT Number ^ICMJE

NCT00526487

Other Study ID Numbers ^ICMJE

07-004, 370010, TXD

Has Data Monitoring Committee

Responsible Party

Cook ( William Cook Europe )

Study Sponsor ^ICMJE

William Cook Europe

Collaborators ^ICMJE

Cook
MED Institute, Incorporated
William Cook Australia

Investigators ^ICMJE

Principal Investigator:

Joseph Lombardi, MD

Thomas Jefferson University

Information Provided By

Cook

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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