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Zenith® Dissection Clinical Trial

NCT01568320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2021-03-16

Study results available
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Summary

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.

Conditions

  • Aortic Dissection

Interventions

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.

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Principal Investigators

  • Joseph Lombardi, MD · The Cooper Health System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-02-28
Completion
2020-01-27
FDA Device
Yes

Countries

  • United States
  • Japan

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 NCT01568320 on ClinicalTrials.gov