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Zenith® Dissection Clinical Trial

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: NCT01568320
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Dissection Device: Endovascular Treatment (Zenith) Not Applicable

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
Study Start Date : August 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : January 27, 2020

Arm Intervention/treatment
Experimental: Endovascular
Endovascular Treatment (Zenith)
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




Primary Outcome Measures :
  1. Freedom from major adverse events [ Time Frame: 30 days ]
    Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support

  2. Survival rate [ Time Frame: 30 days ]
    Freedom from all cause mortality



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

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.

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): NCT01568320


Locations
Show Show 24 study locations
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: Joseph Lombardi, MD The Cooper Health System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT01568320    
Other Study ID Numbers: 11-007
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Aorta
Thoracic
Aortic dissection
Rupture
Type B
DeBakey type III
Endovascular
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases