Zenith(R) Connection Endovascular Covered Stent Clinical Study

NCT ID: NCT00893620

Last Updated: 2017-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aorto-iliac Aneurysms Iliac Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Treatment

Group Type OTHER

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Zenith(R) Connection Endovascular Covered Stent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Christine E. Lynn Heart and Vascular Institute

Locations

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St. Bonifatius Hospital GmbH

Lingen, , Germany

Site Status

St. Franziskus Hospital

Münster, , Germany

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

Countries

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Germany Hong Kong United Kingdom

Other Identifiers

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370020, BVCT

Identifier Type: -

Identifier Source: secondary_id

08-007

Identifier Type: -

Identifier Source: org_study_id

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