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Zenith(R) Connection Endovascular Covered Stent Clinical Study

This study has been terminated.
(Due to less than expected enrollment rates, Cook has reevaluated the need for this clinical study.)
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00893620
First received: April 27, 2009
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Deployment and procedural outcome [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: January 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zenith(R) Connection Endovascular Covered Stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893620

Locations
Germany
St. Bonifatius Hospital GmbH
Lingen, Germany, 49808
St. Franziskus Hospital
Muenster, Germany
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Anthony Lee, MD Christine E. Lynn Heart and Vascular Institute
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00893620     History of Changes
Other Study ID Numbers: 08-007, 370020, BVCT
Study First Received: April 27, 2009
Last Updated: January 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cook:
iliac aneurysm
endovascular repair

Additional relevant MeSH terms:
Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013