CompletedNot Applicable

STACCATO: Stent sTrut Apposition and Coverage in Coronary ArTeries: an Optical Coherence Tomography (OCT) Study

Belgium64 participantsStarted 2009-06

Plain-language summary

Assessment of vessel healing after DES implantation in STEMI, NSTEMI and stable/unstable angina patients: a randomized comparison between everolimus and biolimus A9-eluting stents: an optical coherence tomography (OCT) and intravascular ultrasound-tissue characterisation (IVUS-TC) study. Plaque characterisation substudy: Assessment of culprit lesions in different subsets of patients (STEMI, NSTEMI and stable/unstable angina) by use of optical coherence tomography (OCT) and intravascular ultrasound tissue characterisation (IVUS-TC).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient older than 18 years
✓. Written informed consent available
✓. Patient eligible for percutaneous coronary intervention
✓. patients with a single or multiple de novo lesion(s) from 3 different patient subsets (STEMI, NSTEMI, stable/unstable angina). Target reference vessel diameter measured by QCA: 2-4 mm

Exclusion criteria

✕. Left ventricular ejection fraction of \< 30%
✕. Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
✕. Impaired renal function (serum creatinine \> 2.0 mg/dl)
✕. Target lesion located in bifurcation
✕. Lesion of the left main trunk \> 50%, unprotected
✕. Known allergies to antiplatelet, anticoagulation therapy, contrast media, everolimus or biolimus A9

What they're measuring

Stent strut coverage and stent strut apposition, assessed with OCT

Timeframe: 9 months

Trial details

NCT IDNCT01065519

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02

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