PRESERVE-Zenith® Iliac Branch Clinical Study

This study is currently recruiting participants.
Verified March 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01208415
First received: September 23, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The PRESERVE-Zenith® Iliac Branch Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™/Atrium iCAST™ covered stent in the treatment of aorto-iliac and iliac aneurysms.


Condition Intervention
Aorto-iliac Aneurysms
Iliac Aneurysms
Device: Endovascular repair for aortoiliac or iliac aneurysms.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PRESERVE-Zenith® Iliac Branch Clinical Study

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from patency-related intervention [ Time Frame: Procedure through 6-months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Implant Device: Endovascular repair for aortoiliac or iliac aneurysms.
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™/Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft.
Other Name: Endovascular repair for aortoiliac or iliac aneurysm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An aortoiliac or iliac aneurysm of appropriate size
  • Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria:

  • Less than 18 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Unsuitable arterial anatomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208415

Contacts
Contact: Ryan Schoch 765-463-7537 rschoch@medinst.com

  Show 27 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: W. Anthony Lee, MD, FACS Christine E. Lynn Heart and Vascular Institute
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01208415     History of Changes
Other Study ID Numbers: 05-625
Study First Received: September 23, 2010
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Zenith aortoiliac aneurysm
iliac aneurysm
branch
connections
endovascular graft
graft-iliac bifurcation
Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases

Additional relevant MeSH terms:
Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014