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Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

NCT00880230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2016-02-26

Study results available
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Summary

The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.

Conditions

Interventions

DEVICE

Scuba Iliac Stent System

The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Bruce H Gray, DO · Greeville Health System

  • Barry T Katzen, MD · Baptist Health South Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-06-30
Completion
2012-12-31

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880230 on ClinicalTrials.gov