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Zenith(R) Connection Endovascular Covered Stent Clinical Study

Primary Purpose

Aorto-iliac Aneurysms, Iliac Aneurysms

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aorto-iliac Aneurysms focused on measuring iliac aneurysm, endovascular repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Bonifatius Hospital GmbH
  • St. Franziskus Hospital
  • Queen Mary Hospital
  • Manchester Royal Infirmary

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Treatment

Outcomes

Primary Outcome Measures

Deployment and procedural outcome

Secondary Outcome Measures

Full Information

First Posted
April 27, 2009
Last Updated
February 13, 2017
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00893620
Brief Title
Zenith(R) Connection Endovascular Covered Stent Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Due to less than expected enrollment rates, Cook has reevaluated the need for this clinical study.
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aorto-iliac Aneurysms, Iliac Aneurysms
Keywords
iliac aneurysm, endovascular repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Treatment
Intervention Type
Device
Intervention Name(s)
Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft
Other Intervention Name(s)
Zenith(R) Connection Endovascular Covered Stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Deployment and procedural outcome
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Lee, MD
Organizational Affiliation
Christine E. Lynn Heart and Vascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Bonifatius Hospital GmbH
City
Lingen
ZIP/Postal Code
49808
Country
Germany
Facility Name
St. Franziskus Hospital
City
Muenster
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

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Zenith(R) Connection Endovascular Covered Stent Clinical Study

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