NCT01055275

Brief Summary

The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

January 22, 2010

Last Update Submit

June 19, 2013

Conditions

Iliac AneurysmAortic Aneurysm

Keywords

iliac aneurysmaortic aneurysmendovascular grafts

Outcome Measures

Primary Outcomes (2)

  • Internal iliac artery patency

    1 year

  • Aneurysm Exclusion

    1 year

Secondary Outcomes (5)

  • Death

    1 year

  • Conversion

    1 year

  • Rupture

    1 year

  • Success Measures

    1 year

  • Major Complications

    1 year

Study Arms (1)

Cook Iliac Branch Graft

Patients implanted with a Cook Iliac Branch Graft

Device: Implantation with a Cook Iliac Branch Graft

Interventions

Implantation with a Cook Iliac Branch GraftDEVICE

Treatment of an aortic, aorto-iliac or iliac aneurysm with a CE-marked Cook Iliac Branch Graft.

Cook Iliac Branch Graft

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with a Cook Iliac Branch Graft.

You may qualify if:

  • CE-Marked Cook Iliac Branch Graft (e.g., Zenith® Branch Endovascular Graft-Iliac Bifurcation, Zenith® Helical Branch Endovascular Graft)
  • Registry data are de-identified with respect to patient.

You may not qualify if:

  • Patient for whom this device would not normally be considered standard of care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Iliac AneurysmAortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Vincent Riambau, MD, PhD

    Hospital Clinic, Barcelona, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 25, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

ES(1)