NCT01326884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

March 21, 2011

Last Update Submit

March 11, 2013

Conditions

Abdominal Aortic AneurysmAorto-iliac AneurysmIliac Aneurysm

Keywords

aortic aneurysmiliac aneurysmendovascular procedures

Outcome Measures

Primary Outcomes (1)

  • Composite rate of adverse clinical/device events

    During (day 1) and after implantation through 12 months

Study Arms (1)

1

OTHER

Endovascular Repair

Device: ZLP

Interventions

ZLPDEVICE

ZLP Graft

1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nara Medical University

Nara, 634-8522, Japan

Location

Jikei University Hospital

Tokyo, 105-8461, Japan

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalIliac AneurysmAortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Ronald M. Fairman, MD

    University of Pennsylvania

    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

March 21, 2011

First Posted

March 31, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

JP(2)