Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection

February 27, 2017 updated by: William Cook Europe

Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Australia
      • Melbourne, Australia, VIC 3065
        • St. Vincent's Hospital Melbourne
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • St. Anne's Universtiy Hospital Brno
  • France
    • Cedex
      • Lille, Cedex, France, 59037
        • CHRU de Lille
  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School
      • Leipzig, Germany, 04289
        • Heart Center Leipzig / Park Hospital
      • Rostock, Germany, 18057
        • Clinic of Internal Medicine, University Hospital Rostock
  • Italy
      • Milan, Italy, 20129
        • Hospital San Raffaele
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo

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 greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)

Exclusion Criteria:

  • Age less than 18 years
  • Frank rupture
  • Diagnosed or suspected congenital degenerative connective tissue disease
  • Systemic infection
  • Untreatable reaction to contrast
  • Surgical/endovascular AAA repair within 30 days
  • Previous placement of thoracic endovascular graft
  • Prior repair of descending thoracic aorta
  • Interventional/open procedures within 30 days
  • Onset of symptoms > 3 months

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Endovascular Repair
Device: Zenith® Dissection Endovascular System
The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
Device: Endovascular Repair
Endovascular Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is survival at 30 days
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Cook Europe

Collaborators

Cook Group Incorporated
MED Institute, Incorporated
William Cook Australia

Investigators

  • Principal Investigator: Joseph Lombardi, MD, Thomas Jefferson University

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.

General Publications

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)

July 1, 2011

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-004
  • 370010, TXD

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 Involving the Descending Thoracic Aorta

Clinical Trials on Zenith® Dissection Endovascular System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe