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VISIBILITY™ Iliac 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: NCT01402700
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : September 16, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 26, 2011
Results First Submitted Date  ICMJE August 11, 2015
Results First Posted Date  ICMJE September 16, 2015
Last Update Posted Date March 7, 2018
Study Start Date  ICMJE July 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
Major Adverse Event Rate at 9 Months [ Time Frame: 9 months ]
The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
Major Adverse Event Rate [ Time Frame: 9 months ]
Change History Complete list of historical versions of study NCT01402700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VISIBILITY™ Iliac Study
Official Title  ICMJE Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)
Brief Summary The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Arterial Disease
  • Claudication
Intervention  ICMJE Device: Visi-Pro™ Balloon Expandable Stent System
Implantation of one or more study devices in the common and/or external iliac artery.
Study Arms  ICMJE Experimental: Visi-Pro™ Balloon Expandable Stent System
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Intervention: Device: Visi-Pro™ Balloon Expandable Stent System
Publications * Rundback JH, Peeters P, George JC, Jaff MR, Faries PL. Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months. J Endovasc Ther. 2017 Jun;24(3):342-348. doi: 10.1177/1526602817692960. Epub 2017 Feb 1.

*   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: July 25, 2011)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
  • Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
  • Willing to comply with all follow-up evaluations at the specified times.
  • Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

  • Previous implantation of stent(s) in the target vessel.
  • Received endovascular treatment of the target lesion within six months prior to the index procedure.
  • Known hypersensitivity to contrast material that cannot be adequately pretreated.
  • Known hypersensitivity to 316L stainless Steel.
  • Life expectancy of less than 12 months
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 Belgium
 
Administrative Information
NCT Number  ICMJE NCT01402700
Other Study ID Numbers  ICMJE CP-1000
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter L. Faries, M.D. Icahn School of Medicine at Mount Sinai
Principal Investigator: John H. Rundback, M.D. Holy Name Medical Center
PRS Account Medtronic Endovascular
Verification Date February 2018

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