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VISIBILITY™ Iliac Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402700
First Posted: July 26, 2011
Last Update Posted: March 16, 2017
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.
Information provided by (Responsible Party):
Medtronic Endovascular
  Purpose
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.

Condition Intervention Phase
Peripheral Arterial Disease Claudication Device: Visi-Pro™ Balloon Expandable Stent System Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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.


Enrollment: 75
Study Start Date: July 2011
Study Completion Date: September 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Visi-Pro™ Balloon Expandable Stent System
Implantation of one or more study devices in the common and/or external iliac artery.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01402700


Locations
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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
  More Information

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01402700     History of Changes
Other Study ID Numbers: CP-1000
First Submitted: July 25, 2011
First Posted: July 26, 2011
Results First Submitted: August 11, 2015
Results First Posted: September 16, 2015
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Medtronic Endovascular:
Peripheral arterial disease
claudication
stent
VISI-Pro
Iliac artery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases