- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01568320
Zenith® Dissection Clinical Trial
February 23, 2021 updated by: Cook Research Incorporated
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Expanded Access
Approved for sale to the public.
See expanded access record.
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
- Jikei University School of Medicine
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Tampa, Florida, United States, 33606
- University of South Florida
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Indiana
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Indianapolis, Indiana, United States, 46250
- Indiana Heart Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Hospital
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Missouri
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Saint Louis, Missouri, United States, 63110
- Barnes-jewish Hospital
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New York
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New York, New York, United States, 10016
- New York University Hospital
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- The Christ Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Texas
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Houston, Texas, United States, 77030
- The Methodist Hospital
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Temple, Texas, United States, 76508
- Scott and White Hospital
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Medical Center
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Norfolk, Virginia, United States, 23507
- Sentara Vascular Specialists
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Washington
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Seattle, Washington, United States, 98104
- University of Washington-Harborview Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Exclusion Criteria:
- Age < 18 years;
- 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);
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
- Unwilling or unable to comply with the follow-up schedule;
- Inability or refusal to give informed consent;
- 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.);
- Additional medical restrictions as specified in the Clinical Investigation Plan; or
- Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Endovascular
Endovascular Treatment (Zenith)
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Freedom From Major Adverse Events
Time Frame: 30 days
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Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
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30 days
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Survival Rate at 30 Days
Time Frame: 30 days
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Primary effectiveness endpoint is freedom from all cause mortality at 30 days
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Lombardi, MD, The Cooper Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
January 27, 2020
Study Registration Dates
First Submitted
March 29, 2012
First Submitted That Met QC Criteria
March 30, 2012
First Posted (Estimate)
April 2, 2012
Study Record Updates
Last Update Posted (Actual)
March 16, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Dissection
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Centre Cardiologique du NordUniversita degli Studi di Genova; Henri Mondor University Hospital; Pitié-Salpêtrière...Enrolling by invitationAortic Valve Insufficiency | Aortic Diseases | Ascending Aortic Dissection | Aortic Arch | Aortic Root Dissection | Aortic Root Dilatation | Type A Aortic DissectionFrance
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Assiut UniversityRecruitingAortic Root Aneurysm | Aortic Root DissectionEgypt
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The University of Texas Health Science Center,...RecruitingACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy (ACUTE-B)Distal Aortic Dissection | Dissection, Aortic Acute | Acute Type B Aortic Dissection (Uncomplicated)United States
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Petrovsky National Research Centre of SurgeryRecruitingThoracic Aortic Aneurysm | Thoracic Aortic Dissection | Cardiac Valve Disease | Aortic Aneurysm and DissectionRussian Federation
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University of PennsylvaniaBolton MedicalEnrolling by invitationThoracic Aortic Aneurysm | Thoracic Aortic Dissection | MicroemboliUnited States
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The University of Texas Health Science Center,...Washington University School of Medicine; University of Michigan; John Ritter...Active, not recruiting
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Braile Biomedica Ind. Com. e Repr. Ltda.RecruitingThoracic Aortic DissectionBrazil
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IRCCS San RaffaeleNot yet recruitingAneurysm | Aortic Arch | Dissection, Aortic
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Hangzhou Endonom Medtech Co., Ltd.RecruitingAortic Aneurysm and DissectionChina
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Xiaotong HouNot yet recruitingAcute Aortic DissectionChina
Clinical Trials on Endovascular Treatment (Zenith)
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Cook Research IncorporatedApproved for marketingAortic DissectionUnited States
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Cook Group IncorporatedCompleted
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Cook Group IncorporatedApproved for marketingAortic Aneurysm | Vascular Disease | Penetrating UlcerUnited States
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William Cook EuropeCook Group Incorporated; MED Institute, Incorporated; William Cook AustraliaCompletedAortic Dissection Involving the Descending Thoracic AortaItaly, Germany, Australia, Czech Republic, France
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Cook Research IncorporatedCompletedThoracic Injuries | Thoracic Aorta | Blunt InjuriesUnited States
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Cook Research IncorporatedCompletedAortic Aneurysm, AbdominalUnited States
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The Cleveland ClinicMassachusetts General HospitalCompletedAbdominal Aortic Aneurysm | Thoracoabdominal AneurysmUnited States
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The Cleveland ClinicCompletedAbdominal Aortic Aneurysm | Iliac Aneurysm | Internal Iliac AneurysmUnited States
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Cook Research IncorporatedCompletedAortic Aneurysm | Vascular Disease | Penetrating UlcerUnited States, Japan, Germany, Italy, Sweden, United Kingdom
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Cook Group IncorporatedTerminatedAorto-iliac Aneurysms | Iliac AneurysmsHong Kong, United Kingdom, Germany