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A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation

NCT01637896 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2012-07-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis

Conditions

  • Myocardial Ischemia

Interventions

DEVICE

DEB+BMS

drug-eluting balloon predilation and bare metal stent implantation

DEVICE

POBA+DES

conventional balloon predilation and drug-eluting stent implantation

Sponsors & Collaborators

  • Leonardo Bolognese, MD

    lead OTHER

Principal Investigators

  • Leonardo Bolognese, MD · San Donato Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-12-31
Completion
2012-07-31

Countries

  • Italy

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 NCT01637896 on ClinicalTrials.gov