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

NCT01103765 | Unknown Phase 4

• 1 other identifier: UK0801
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Optimal stent deployment defined by IVUS analysis

  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

  at 18 months

Secondary Outcomes (1)

• Complications of percutaneous coronary intervention (PCI)

  at day0, at day1, at the end of hospitalisation and year1

Study Arms (2)

classic strategy

PLACEBO COMPARATOR

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

Procedure: stent deployment without post-dilatation

post-dilatation strategy

ACTIVE COMPARATOR

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.

Procedure: post dilatation after stent deployment

Interventions

post dilatation after stent deployment PROCEDURE

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

post-dilatation strategy

stent deployment without post-dilatation PROCEDURE

stent deployment without systematic post dilatation

classic strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful drug eluting stent implantation in a native coronary artery

You may not qualify if:

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

Sponsors & Collaborators

• Recherches et etudes en sciences sociales et sante, France: lead

Study Sites (1)

Service de cardiologie interventionnelle - Hôpital Lariboisière

Paris, 75010, France

RECRUITING

Study Officials

• Georgios SIDERIS, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios SIDERIS, MD

CONTACT

33(1) 01-49-95-82-04; georgios.sideris@lrb.aphp.fr

Olivier VARENNE, MD

CONTACT

33(1) 58-41-16-53; olivier.varenne@cch.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

FR (1)