PRESERVE-Zenith® Iliac Branch Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01208415
First received: September 23, 2010
Last updated: September 29, 2014
Last verified: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208415

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

  Show 23 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: September 29, 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 October 19, 2014