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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
History of Changes
  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:

U.S. FDA Resources

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
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
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013