NCT00196092

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
819

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

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

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 12, 2015

Status Verified

December 1, 2007

First QC Date

September 13, 2005

Last Update Submit

March 11, 2015

Conditions

Abdominal Aortic Aneurysm

Study Arms (8)

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

Device: Standard Risk Continued Access

8

OTHER

High Risk Continued Access

Device: High Risk Continued Access

Interventions

Roll-inDEVICE

Proctored entry.

1
SurgicalDEVICE

Surgery

2
Standard RiskDEVICE

Standard Endovascular repair

3
High RiskDEVICE

High Risk Endovascular repair.

4
Compassionate UseDEVICE

Endovascular repair for compassionate use patients.

5
Treatment for femalesDEVICE

Endovascular repair in female patients

6
Standard Risk Continued AccessDEVICE

Continued Access Endovascular repair for standard risk patients.

7
High Risk Continued AccessDEVICE

Continued Access Endovascular Repair for High Risk Patients.

8

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Surgical Procedures, OperativeCompassionate Use TrialsTherapeutics

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Therapies, InvestigationalDrug ApprovalDrug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Roy Greenberg, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2000

Study Completion

July 1, 2006

Last Updated

March 12, 2015

Record last verified: 2007-12