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

NCT00526487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-03-01

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Dissection Involving the Descending Thoracic Aorta

Interventions

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

Sponsors & Collaborators

  • Cook Group Incorporated

    collaborator INDUSTRY

  • MED Institute, Incorporated

    collaborator INDUSTRY

  • William Cook Australia

    collaborator INDUSTRY

  • William Cook Europe

    lead INDUSTRY

Principal Investigators

  • Joseph Lombardi, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-07-31
Completion
2016-09-30

Countries

  • Australia
  • Czechia
  • France
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00526487 on ClinicalTrials.gov