Zenith® Dissection Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01568320
First received: March 29, 2012
Last updated: July 22, 2014
Last verified: July 2014
  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 acute, complicate Type B aortic dissection.


Condition Intervention Phase
Aortic Dissection
Device: Endovascular Treatment (Zenith)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection

Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from major adverse events and survival [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 73
Study Start Date: August 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular Device: Endovascular Treatment (Zenith)
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:
  • Endovascular graft
  • Endovascular stent
  • Stent-graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria:

  1. Age < 18 years;
  2. 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);
  3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
  4. Unwilling or unable to comply with the follow-up schedule;
  5. Inability or refusal to give informed consent;
  6. 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.);
  7. Additional medical restrictions as specified in the Clinical Investigation Plan; or
  8. 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: NCT01568320

Contacts
Contact: Amy Griggs 800-356-9208 agriggs@medinst.com

  Show 30 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Joseph Lombardi, MD The Cooper Health System
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01568320     History of Changes
Other Study ID Numbers: 11-007
Study First Received: March 29, 2012
Last Updated: July 22, 2014
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 October 16, 2014