Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical... | NCT01326884

Studies
Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

NCT01326884

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Mar 12, 2013Estimated

Enrollment

27Actual

Phase

Not Applicable

Conditions

Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Iliac Aneurysm

Interventions

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Mar 21, 2011

First Submission Date that Met QC Criteria

Mar 30, 2011

First Posted Date

Mar 31, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2013

Last Update Posted Date

Mar 12, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Endovascular Repair	Device: ZLP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZLP	Device	ZLP Graft	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite rate of adverse clinical/device events		During (day 1) and after implantation through 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald M. Fairman, MD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nara Medical University		Nara		634-8522	Japan
Jikei University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal
D017543	Iliac Aneurysm
D001014	Aortic Aneurysm

Ancestor Terms

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided