- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464943
Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections
January 15, 2020 updated by: Cook Research Incorporated
Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissections
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
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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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia 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:
- < 18 years of age
- Other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., < 2 years)
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Unwilling to 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)
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?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
June 4, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 15, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-007-CA
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 IncorporatedCompleted
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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