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

Recherches et etudes en sciences sociales et sante, France

Status and phase: Unknown; Phase 4

Conditions: Implant

Treatments: Procedure: post dilatation after stent deployment; Procedure: stent deployment without post-dilatation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01103765

UK0801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups, including a placebo group

classic strategy

Placebo Comparator group

Description:

after drug-eluting stent(DES) deployment perform of Intravascular ultrasound analysis without post-dilatation

Treatment:

Procedure: stent deployment without post-dilatation

post-dilatation strategy

Active Comparator group

Description:

After drug-eluting stent (DES) deployment IVUS analysis and systematic post-dilatation with noncompliant balloon 0.25mm larger than stent balloon. After post dilatation new IVUS analysis.

Treatment:

Procedure: post dilatation after stent deployment