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NCT01055275 Clinical Trial

Cook Iliac Branch Graft Post-market Registry

Aortic Aneurysm Clinical Trial

Official title:
Cook Iliac Branch Graft Post-market Registry

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01055275
Other study ID # 09-016
Secondary ID
Status Terminated
Phase N/A
First received January 22, 2010
Last updated June 19, 2013
Start date September 2010
Est. completion date August 2012

Study information
Verified date June 2013
Source Cook
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain Hospital Clinic Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Internal iliac artery patency 1 year No
Primary Aneurysm Exclusion 1 year No
Secondary Death 1 year No
Secondary Conversion 1 year No
Secondary Rupture 1 year No
Secondary Success Measures 1 year No
Secondary Major Complications 1 year No
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