Implant Clinical Trial
Official title:
A Prospective Randomized Multicenter Study of the Efficacy and Safety of Systematic Post -Dilatation With Noncompliant Balloon After Successful Drug-eluting Stent Implantation. IVUS Analysis.
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.
Stent expansion of DES using current stent deliver systems is frequently suboptimal. Further
more smaller minimal stent area (MSA) and stent underexpansion following deployment of DES
are strong predictors of stent thrombosis and (TVR) target vessel revascularization. The
investigators hypothesize than adjunctive postdilatation with noncompliant balloon can
improve DES deployment.
After successful drug eluting stent implantation, patients will be randomized into two
groups: Group A with no further dilatation, and Group B with additional post-dilatation with
a noncompliant balloon. The investigators will performed IVUS analysis in groups A and B
just before randomization and after post-dilatation in group B. Post dilatation will be
performed with noncompliant balloon and with a nominal diameter 0.25mm larger than stent
balloon.
The primary endpoint is optimum stent deployment. For defining the optimal stent deployment
the investigators use the IVUS criteria adopted in the MUSIC study: Complete apposition
without underexpansion and with symmetric stent expansion.
Patients are eligible after successful drug-eluting stent implantation in a native coronary
artery. Patients with myocardial infarction or acute coronary syndrome will be excluded from
the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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