This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Endovascular Identifier:
First received: July 25, 2011
Last updated: September 25, 2015
Last verified: August 2015
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
Device: Visi-Pro™ Balloon Expandable Stent System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)

Resource links provided by NLM:

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Major Adverse Event Rate at 9 Months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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
Estimated Study Completion Date: January 2016
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01402700

United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States
Sponsors and Collaborators
Medtronic Endovascular
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

No publications provided

Responsible Party: Medtronic Endovascular Identifier: NCT01402700     History of Changes
Other Study ID Numbers: CP-1000
Study First Received: July 25, 2011
Results First Received: August 11, 2015
Last Updated: September 25, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Peripheral arterial disease
Iliac artery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on November 27, 2015