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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00526487
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : March 1, 2017
Sponsor:
Collaborators:
Cook Group Incorporated
MED Institute, Incorporated
William Cook Australia
Information provided by (Responsible Party):
Cook Group Incorporated ( 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.

Condition or disease Intervention/treatment Phase
Aortic Dissection Involving the Descending Thoracic Aorta Device: Zenith® Dissection Endovascular System Device: Endovascular Repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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
Study Start Date : December 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2016

Arm Intervention/treatment
1
Endovascular Repair
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




Primary Outcome Measures :
  1. The primary endpoint is survival at 30 days [ Time Frame: 30 days ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526487


Locations
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Australia
St. Vincent's Hospital Melbourne
Melbourne, Australia, VIC 3065
Czech Republic
St. Anne's Universtiy Hospital Brno
Brno, Czech Republic, 656 91
France
CHRU de Lille
Lille, Cedex, France, 59037
Germany
Hannover Medical School
Hannover, Germany, 30625
Heart Center Leipzig / Park Hospital
Leipzig, Germany, 04289
Clinic of Internal Medicine, University Hospital Rostock
Rostock, Germany, 18057
Italy
Hospital San Raffaele
Milan, Italy, 20129
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
William Cook Europe
Cook Group Incorporated
MED Institute, Incorporated
William Cook Australia
Investigators
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Principal Investigator: Joseph Lombardi, MD Thomas Jefferson University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William Cook Europe
ClinicalTrials.gov Identifier: NCT00526487    
Other Study ID Numbers: 07-004
370010, TXD
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Cook Group Incorporated ( William Cook Europe ):
Thoracic Dissection
Dissection
Endovascular
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases