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Post-dilatation for Optimization of Drug-eluting Stents (DES) Deployment Assessed by Intravascular Ultrasound Multicenter Analysis

NCT01103765 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2011-06-16

No results posted yet for this study

Summary

Comparison with use of Intravascular Ultrasound (IVUS) analysis of two methods of percutaneous coronary interventions (PCI) with drug eluting stent:

After successful drug eluting stent implantation, patients were randomized into two groups: Group A had no further dilatation, and Group B had additional post-dilatation with a noncompliant balloon. The investigators performed IVUS analysis in groups A and B just before randomization and after post-dilatation in group B.

Conditions

  • Implant

Interventions

PROCEDURE

post dilatation after stent deployment

Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.

PROCEDURE

stent deployment without post-dilatation

stent deployment without systematic post dilatation

Sponsors & Collaborators

  • Recherches et etudes en sciences sociales et sante, France

    lead NETWORK

Principal Investigators

  • Georgios SIDERIS, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • France

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 NCT01103765 on ClinicalTrials.gov