Trial record 3 of 14 for:    Cook Dissection

Zenith® Dissection Endovascular System (STABLE I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT02094300
First received: February 21, 2014
Last updated: October 14, 2015
Last verified: October 2015
  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 patients with aortic dissection.

Condition Intervention
Aortic Dissection
Device: Zenith® Dissection Endovascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zenith® Dissection Endovascular System

Further study details as provided by Cook:

Primary Outcome Measures:
  • Number of Patients With Major Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 26
Study Start Date: December 2007
Estimated Study Completion Date: February 2017
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  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: 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
Investigators
Principal Investigator: Joseph Lombardi, MD The Cooper Health System
  More Information

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT02094300     History of Changes
Other Study ID Numbers: 05-622 
Study First Received: February 21, 2014
Results First Received: August 13, 2015
Last Updated: October 14, 2015
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 August 25, 2016