Zenith® Dissection Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01568320
First received: March 29, 2012
Last updated: July 22, 2014
Last verified: July 2014
  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 Phase
Aortic Dissection
Device: Endovascular Treatment (Zenith)
Phase 3

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 ]

Estimated Enrollment: 73
Study Start Date: August 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular 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
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

Contacts
Contact: Amy Griggs 800-356-9208 agriggs@medinst.com

  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ali Khoynezhad, MD    310-423-3851    Ali.Khoynezhad@cshs.org   
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Michael Fischbein, MD    650-724-0831    mfischbe@stanford.edu   
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Adam Beck, MD    352-273-5484    adam.beck@surgery.ufl.edu   
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Karl Illig, MD    813-844-4500    killig@health.usf.edu   
United States, Indiana
Indiana Heart Hospital Completed
Indianapolis, Indiana, United States, 46250
United States, Maryland
University of Maryland Medical Center Withdrawn
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Marc Schermerhorn, MD    617-632-9971    mscherm@bidmc.harvard.edu   
Massachusetts General Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard Cambria, MD    617-726-8278    rcambria@partners.org   
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Andres Schanzer, MD    508-856-5599    schanzea@ummhc.org   
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Himanshu Patel, MD    734-936-4984    hjpatel@umich.edu   
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Luis Sanchez, MED    314-362-7408    sanchezl@wudosis.wustl.edu   
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Mark Fillinger, MD    603-650-8677    mark.f.fillinger@hitchcock.org   
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Francis Caputo, MD    856-342-2151    Caputo-Francis@CooperHealth.edu   
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Michael Wilderman, MD    201-343-0040    michael.wilderman@gmail.com   
United States, New York
Montefiore Medical Center Withdrawn
Bronx, New York, United States, 10467
New York University Hospital Recruiting
New York, New York, United States, 10016
Contact: Thomas Maldonado, MD    212-263-7311    thomas.maldonado@nyumc.org   
United States, North Carolina
University of North Carolina Hospital Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mark Farber, MD    919-966-3391    farberm@med.unc.edu   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Chad Hughes, MD    919-668-0903    gchad.hughes@duke.edu   
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Todd Bayer, MD    513-421-3494    tbayer@zoomtown.com   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nimesh Desai, MD    215-615-0343    nimesh.desai@uphs.upenn.edu   
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Thomas Gleason, MD    412-802-8529    gleasontg@upmc.edu   
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Satish Muluk, MD    412-359-3714    muluk@usa.net   
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Jeffrey Slaiby, MD    401-553-8333    jslaiby@usasurg.org   
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jean Bismuth, MD    713-441-5200    jbismuth@tmhs.org   
Scott and White Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Marvin Atkins, MD    254-724-0657    matkins@swmail.sw.org   
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Gilbert Upchurch, MD    434-924-9279    GRU6N@hscmail.mcc.virginia.edu   
Sentara Vascular Specialists Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jean Panneton, MD    757-622-2649    jmpannet@sentara.com   
United States, Washington
University of Washington-Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Benjamin Starnes, MD    206-744-3000    starnes@u.washington.edu   
Japan
Osaka University Hospital Recruiting
Osaka, Japan
Contact: Toru Kuratani, MD         
Jikei University School of Medicine Recruiting
Tokyo, Japan
Contact: Takao Ohki, MD    +81-3-3433-1111 ext 3400    takohki@msn.com   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Joseph Lombardi, MD Cooper University Hospital
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01568320     History of Changes
Other Study ID Numbers: 11-007
Study First Received: March 29, 2012
Last Updated: July 22, 2014
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 23, 2014