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PRESERVE-Zenith® Iliac Branch System Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01208415
Recruitment Status : Completed
First Posted : September 24, 2010
Results First Posted : August 16, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
The PRESERVE-Zenith® Iliac Branch System 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™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

Condition or disease Intervention/treatment Phase
Aorto-iliac Aneurysms Iliac Aneurysms Device: Endovascular repair for aortoiliac or iliac aneurysms. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRESERVE-Zenith® Iliac Branch System Clinical Study
Study Start Date : January 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
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™ and the Zenith® Flex AAA Endovascular Graft.
Other Name: Endovascular repair for aortoiliac or iliac aneurysm.




Primary Outcome Measures :
  1. Patients That Are Free From Patency-related Intervention [ Time Frame: 6 Months ]
    Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208415


Locations
Show Show 19 study locations
Sponsors and Collaborators
Cook Group Incorporated
Investigators
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Principal Investigator: W. Anthony Lee, MD, FACS Christine E. Lynn Heart and Vascular Institute
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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01208415    
Other Study ID Numbers: 05-625-P1
First Posted: September 24, 2010    Key Record Dates
Results First Posted: August 16, 2017
Last Update Posted: April 4, 2018
Last Verified: September 2017
Keywords provided by Cook Group Incorporated:
Zenith aortoiliac aneurysm
iliac aneurysm
branch
connections
endovascular graft
graft-iliac bifurcation
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Additional relevant MeSH terms:
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Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases