NCT00893620

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 14, 2017

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

April 27, 2009

Last Update Submit

February 13, 2017

Conditions

Aorto-iliac AneurysmsIliac Aneurysms

Keywords

iliac aneurysmendovascular repair

Outcome Measures

Primary Outcomes (1)

  • Deployment and procedural outcome

    30 days

Study Arms (1)

1

OTHER

Treatment

Device: Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft

Interventions

Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular GraftDEVICE

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.

Also known as: Zenith(R) Connection Endovascular Covered Stent
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St. Bonifatius Hospital GmbH

Lingen, 49808, Germany

Location

St. Franziskus Hospital

Münster, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Iliac Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Anthony Lee, MD

    Christine E. Lynn Heart and Vascular Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

May 6, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 14, 2017

Record last verified: 2012-01

Locations

HK(1)DE(2)GB(1)