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Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01326884
First received: March 21, 2011
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.


Condition Intervention
Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Iliac Aneurysm
 Device: ZLP

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Composite rate of adverse clinical/device events [ Time Frame: During (day 1) and after implantation through 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Endovascular Repair
 Device: ZLP
ZLP Graft

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size
  • Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

  • Less than 20 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: NCT01326884

Locations
Japan
Nara Medical University
Nara, Japan, 634-8522
Jikei University Hospital
Tokyo, Japan, 105-8461
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Ronald M. Fairman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01326884     History of Changes
Other Study ID Numbers: 10-004
Study First Received: March 21, 2011
Last Updated: March 11, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Cook:
aortic aneurysm
iliac aneurysm
endovascular procedures

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 19, 2013