Zenith(R) Connection Endovascular Covered Stent Clinical Study

February 13, 2017 updated by: Cook Group Incorporated
The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical investigation to study the safety and performance of the Zenith(R) Connection Endovascular Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation in the treatment of aorto-iliac and iliac aneurysms.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

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

  • Germany
      • Lingen, Germany, 49808
        • St. Bonifatius Hospital GmbH
      • Muenster, Germany
        • St. Franziskus Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary

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:

  • An aortoiliac or iliac aneurysm of appropriate size
  • Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria:

  • Less than 18 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Unsuitable arterial anatomy

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Treatment
Device: Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft
These devices will be used in patients with an unsuitable distal sealing site for the standard Zenith(R) iliac leg component proximal to the common iliac bifurcation to maintain internal iliac artery patency with endovascular aneurysm repair.
Other Names:
  • Zenith(R) Connection Endovascular Covered Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Deployment and procedural outcome
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Anthony Lee, MD, Christine E. Lynn Heart and Vascular Institute

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

January 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-007
  • 370020, BVCT

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.

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