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Zenith® Dissection Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01568320
First received: March 29, 2012
Last updated: May 5, 2016
Last verified: May 2016

March 29, 2012
May 5, 2016
August 2012
April 2016   (final data collection date for primary outcome measure)
Freedom from major adverse events and survival [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01568320 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zenith® Dissection Clinical Trial
Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Dissection
Device: Endovascular Treatment (Zenith)
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Other Names:
  • Endovascular graft
  • Endovascular stent
  • Stent-graft
Experimental: Endovascular
Endovascular Treatment (Zenith)
Intervention: Device: Endovascular Treatment (Zenith)
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
73
April 2020
April 2016   (final data collection date for primary outcome measure)

Exclusion Criteria:

  1. Age < 18 years;
  2. Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
  3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
  4. Unwilling or unable to comply with the follow-up schedule;
  5. Inability or refusal to give informed consent;
  6. Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);
  7. Additional medical restrictions as specified in the Clinical Investigation Plan; or
  8. Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Japan
 
NCT01568320
11-007
Not Provided
Not Provided
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Cook
Cook
Not Provided
Principal Investigator: Joseph Lombardi, MD The Cooper Health System
Cook
May 2016

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