Clinical trial NCT01103765: Post-dilatation for Optimization of Drug-eluting Stents (DES) Deployment Assessed by Intravascular Ultrasound Multicenter Analysis
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Implant
Keywords: Post-dilatation
noncompliant balloon
optimal stent deployment of drug-eluting stent
Intravascular ultrasound (IVUS)
Optimal stent deployment defined by intravascular ultrasound analysis
Lead sponsor: Recherches et etudes en sciences sociales et sante, France
Sponsor class: NETWORK
First posted: 2010-04-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Successful drug eluting stent implantation in a native coronary artery

Exclusion Criteria:

* Percutaneous coronary intervention (PCI) of Left main coronary artery;
* Myocardial infarction;
* Acute coronary syndrome;
* Emergency PCI;
* PCI for in-stent restenosis;

Primary outcomes:
measure: Optimal stent deployment defined by IVUS analysis
timeFrame: at 18 months
Secondary outcomes:
measure: Complications of percutaneous coronary intervention (PCI)
timeFrame: at day0, at day1, at the end of hospitalisation and year1
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de cardiologie interventionnelle - Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Georgios SIDERIS, MD
role: PRINCIPAL_INVESTIGATOR
References: