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Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases

NCT00546312 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2010-05-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and to determine the proportion of patients who experience adverse events during and after the implantation procedure, including disease-specific and overall mortality rates.

Conditions

  • Descending Thoracic Aortic Disease

Interventions

DEVICE

Thoracic EXCLUDER Endoprosthesis

Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

Sponsors & Collaborators

  • Arizona Heart Institute

    lead OTHER

Principal Investigators

  • Edward B Diethrich, M.D. · Arizona Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

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 NCT00546312 on ClinicalTrials.gov