The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation 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: NCT02571907
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date June 28, 2021
Actual Study Start Date  ICMJE April 1, 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2015)		 Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2015)		 Freedom from patency-related intervention [ Time Frame: 6 months ]
Secondary intervention to treat a > 60% stenosis of the internal iliac artery associated with clinical symptoms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2015)		 Freedom from morbidity (i.e., morbidity index) [ Time Frame: 30 days ]
Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
Official Title  ICMJE Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
Brief Summary The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortoiliac Aneurysms
  • Iliac Aneurysms
Intervention  ICMJE
  • Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,
    Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
    Other Name: Branch Graft
  • Device: Atrium iCAST™
    Implantation of Atrium iCAST
  • Device: Zenith® Flex AAA Endovascular Graft
    Implantation of the Zenith Flex Endovascular Graft
Study Arms  ICMJE Experimental: Zenith® Branch Endovascular Graft-Iliac Bifurcation
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Interventions:
  • Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,
  • Device: Atrium iCAST™
  • Device: Zenith® Flex AAA Endovascular Graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2015)		 40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 4, 2020
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • An aortioiliac or iliac aneurysm
  • An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac 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
  • Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
  • Unwilling or unable to comply with the follow-up schedule
  • Simultaneously participating in another investigative device or drug study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02571907
Other Study ID Numbers  ICMJE 05-625 P2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cook Group Incorporated ( Cook Research Incorporated )
Original Responsible Party Cook Group Incorporated
Current Study Sponsor  ICMJE Cook Research Incorporated
Original Study Sponsor  ICMJE Cook Group Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: W. Anthony Lee, MD FACS Christine E. Lynn Heart and Vascular Institute
PRS Account Cook Group Incorporated
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP