VISIBILITY™ Iliac Study

NCT01402700 | Completed Results

• 1 other identifier: CP-1000
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Claudication

Keywords

Peripheral arterial disease; claudication; stent; VISI-Pro; Iliac artery

Outcome Measures

Primary Outcomes (1)

• Major Adverse Event Rate at 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.

  9 months

Study Arms (1)

Visi-Pro™ Balloon Expandable Stent System

EXPERIMENTAL

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

Interventions

Visi-Pro™ Balloon Expandable Stent System DEVICE

Implantation of one or more study devices in the common and/or external iliac artery.

Visi-Pro™ Balloon Expandable Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (1)

Holy Name Medical Center

Teaneck, New Jersey, United States

Location

Related Publications (1)

• 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.

  PMID: 28351204 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Cihlar
• Organization: Medtronic

stephanie.a.cihlar@medtronic.com

763-398-7932

Study Officials

• Peter L. Faries, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• John H. Rundback, M.D.

  Holy Name Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2015
• Last Updated: March 7, 2018
• Results First Posted: September 16, 2015

Record last verified: 2018-02

Locations

US (1)