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PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis

NCT00916279 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-02-27

Study results available
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Summary

The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.

Conditions

  • In-Stent Restenosis

Interventions

DEVICE

Lutonix Paclitaxel-Coated Balloon

PTCA

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Laura Mauri, MD · Brigham & Women's Hospital, Boston, MA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-10-31
Completion
2011-12-31

Countries

  • Belgium
  • Germany
  • Netherlands

Study Locations

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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 NCT00916279 on ClinicalTrials.gov