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Trial record 3 of 16 for:    Cook Dissection

Zenith® Dissection Endovascular System (STABLE I)

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ClinicalTrials.gov Identifier: NCT02094300
Recruitment Status : Completed
First Posted : March 21, 2014
Results First Posted : September 14, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Dissection Device: Zenith® Dissection Endovascular Graft Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith® Dissection Endovascular System
Study Start Date : December 2007
Actual Primary Completion Date : February 2012
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Endovascular Device: Zenith® Dissection Endovascular Graft
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:
  • Endovascular graft
  • Stent-graft



Primary Outcome Measures :
  1. Number of Patients With Major Complications [ Time Frame: 30 days ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094300


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Massachusetts
Massachusetss General Hospital
Boston,, Massachusetts, United States, 02114
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadephia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Joseph Lombardi, MD The Cooper Health System

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02094300     History of Changes
Other Study ID Numbers: 05-622
First Posted: March 21, 2014    Key Record Dates
Results First Posted: September 14, 2015
Last Update Posted: February 6, 2017
Last Verified: December 2016

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