Cook Iliac Branch Graft Post-market Registry

Terminated

• Conditions: Iliac Aneurysm; Aortic Aneurysm
• Interventions: Device: Implantation with a Cook Iliac Branch Graft

• Registration Number: NCT01055275
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Study Start: 2010-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cook Iliac Branch Graft	Implantation with a Cook Iliac Branch Graft	Patients implanted with a Cook Iliac Branch Graft

Primary Outcome Measures

Name	Time	Method
Internal iliac artery patency	1 year
Aneurysm Exclusion	1 year

Secondary Outcome Measures

Name	Time	Method
Death	1 year
Conversion	1 year
Rupture	1 year
Success Measures	1 year
Major Complications	1 year

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain