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VISIBILITY™ Iliac Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01402700
First received: July 25, 2011
Last updated: May 9, 2013
Last verified: May 2013
  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: Allocation: Non-Randomized
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 Covidien:

Primary Outcome Measures:
  • Major Adverse Event Rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: July 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01402700

Locations
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Peter L. Faries, M.D. Mount Sinai School of Medicine
Principal Investigator: John H. Rundback, M.D. Holy Name Medical Center
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01402700     History of Changes
Other Study ID Numbers: CP-1000
Study First Received: July 25, 2011
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014