- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02094300
Zenith® Dissection Endovascular System (STABLE I)
December 12, 2016 updated by: Cook Group Incorporated
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 patients with aortic dissection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
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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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Massachusetts
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Boston,, Massachusetts, United States, 02114
- Massachusetss General Hospital
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Pennsylvania
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Philadephia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
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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
Inclusion Criteria:
- Branch vessel obstruction/compromise
- Peri-aortic effusion/hematoma
- Resistant hypertension
- Persistent pain/symptoms
- Transaortic growth >5 mm within 3 months
- Transaortic diameter >40 mm.
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 protocol, 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 24 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 |
---|---|
Experimental: Endovascular
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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 guide 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 |
---|---|---|
Number of Patients With Major Complications
Time Frame: 30 days
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Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.
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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
December 1, 2007
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
February 21, 2014
First Submitted That Met QC Criteria
March 20, 2014
First Posted (Estimate)
March 21, 2014
Study Record Updates
Last Update Posted (Estimate)
February 6, 2017
Last Update Submitted That Met QC Criteria
December 12, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-622
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 Zenith® Dissection Endovascular Graft
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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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Cook Research IncorporatedCompletedIliac Aneurysms | Aortoiliac AneurysmsUnited 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 Research IncorporatedCompletedAbdominal Aortic Aneurysm (AAA) | Aorto-iliac Aneurysm | Juxtarenal AneurysmUnited States
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Cook Group IncorporatedApproved for marketingAbdominal Aortic Aneurysms | Aorto-iliac Aneurysms | Juxtarenal AneurysmsUnited States
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Cook Group IncorporatedCompleted
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Cook Research IncorporatedNo longer availableIliac Aneurysms | Aortoiliac AneurysmsUnited States
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Cook Research IncorporatedCompletedDescending Thoracic Aortic AneurysmUnited States, Canada