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
  Purpose
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 Intervention
Aortic Dissection
Device: Endovascular Treatment (Zenith)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from major adverse events and survival [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 73
Study Start Date: August 2012
Estimated Study Completion Date: April 2020
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568320

  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of South Florida
Tampa, Florida, United States, 33606
United States, Indiana
Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General
Boston, Massachusetts, United States, 02114
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
New York University Hospital
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Sentara Vascular Specialists
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington-Harborview Medical Center
Seattle, Washington, United States, 98104
Japan
Jikei University School of Medicine
Tokyo, Japan
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Joseph Lombardi, MD The Cooper Health System
  More Information

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01568320     History of Changes
Other Study ID Numbers: 11-007 
Study First Received: March 29, 2012
Last Updated: May 5, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Aorta
Thoracic
Aortic dissection
Rupture
Type B
DeBakey type III
Endovascular

ClinicalTrials.gov processed this record on July 28, 2016