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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014