Zenith® AAA Endovascular Graft Clinical Study | NCT00196092

Studies
Zenith® AAA Endovascular Graft Clinical Study

NCT00196092

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Mar 12, 2015Estimated

Enrollment

819Actual

Phase

Not Applicable

Conditions

Abdominal Aortic Aneurysm

Interventions

Roll-in
Surgical
Standard Risk
High Risk
Compassionate Use
Treatment for females
Standard Risk Continued Access
High Risk Continued Access

Countries

Not provided

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

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2000

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

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, 2015

Last Update Posted Date

Mar 12, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.

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

819Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Roll-in	Device: Roll-in
2	Other	Surgical	Device: Surgical
3	Other	Standard Risk	Device: Standard Risk
4	Other	High Risk	Device: High Risk
5	Other	Compassionate Use	Device: Compassionate Use
6	Other	Treatment for females.	Device: Treatment for females
7	Other	Standard Risk Continued Access

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Roll-in	Device	Proctored entry.	1
Surgical

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.

Exclusion Criteria:

Patients less than 18 years of age.
Patient with a life expectancy less than 2 years.
Patients who are pregnant.
Patients unwilling to comply with the follow-up schedule.
Patient inability or refusal to give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Roy Greenberg, M.D.	The Cleveland Clinic	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D057176	Compassionate Use Trials
D013812	Therapeutics

Ancestor Terms

ID	Term
D035703	Therapies, Investigational
D017277	Drug Approval
D000076722	Drug Development
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided