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: February 5, 2014
Last verified: February 2014

September 5, 2007
February 5, 2014
December 2007
May 2016   (final data collection date for primary outcome measure)
The primary endpoint is survival at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The primary endpoint is survival at 30 days
Complete list of historical versions of study NCT00526487 on ClinicalTrials.gov Archive Site
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Dissection Involving the Descending Thoracic Aorta
  • 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
1
Endovascular Repair
Interventions:
  • Device: Zenith® Dissection Endovascular System
  • Device: Endovascular Repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Czech Republic,   France,   Germany,   Italy
 
NCT00526487
07-004, 370010, TXD
No
Cook ( William Cook Europe )
William Cook Europe
  • Cook
  • MED Institute, Incorporated
  • William Cook Australia
Principal Investigator: Joseph Lombardi, MD Thomas Jefferson University
Cook
February 2014

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