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De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions

NCT00934752 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-01-16

No results posted yet for this study

Summary

The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stenting (BMS). The purpose is to assess the feasibility, safety and efficacy of the Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct treatment strategies.

Conditions

  • Coronary Artery Stenosis

Interventions

DEVICE

Lutonix Paclitaxel-Coated Balloon

Percutaneous transluminal coronary angioplasty (PCTA)

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Prof. P.W.J C. Serruys, MD, PhD · Erasmus Universtiy Medical Center; Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-04-30
Completion
2012-01-31

Countries

  • 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 NCT00934752 on ClinicalTrials.gov