Implant
Conditions
Keywords
Post-dilatation, noncompliant balloon, optimal stent deployment of drug-eluting stent, Intravascular ultrasound (IVUS), Optimal stent deployment defined by intravascular ultrasound analysis
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.
Interventions
PROCEDUREpost dilatation after stent deployment
Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.
PROCEDUREstent deployment without post-dilatation
stent deployment without systematic post dilatation
Sponsors
Recherches et etudes en sciences sociales et sante, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal stent deployment defined by IVUS analysis | at 18 months | The primary endpoint is optimum stent deployment. For defining the optimal stent deployment we use the IVUS criteria adopted in the MUSIC study: Complete apposition without underexpansion and with symmetric stent expansion. All patients(group A and B) will have IVUS analysis for defining optimal stent deployment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of percutaneous coronary intervention (PCI) | at day0, at day1, at the end of hospitalisation and year1 | Death,Myocardial infarction, coronary dissection, intracoronary thrombosis, target vessel revascularisation. |
Countries
France
Contacts
Primary ContactGeorgios SIDERIS, MD
Backup ContactOlivier VARENNE, MD
Outcome results
None listed