Angiography Versus (vs) IVUS Optimisation

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: IVUS optimised DES implantation; Procedure: angiographically guided DES implantation

• Registration Number: NCT00936169
• Lead Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Brief Summary

The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-06
• Status Verified: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Study Completion: 2011-07
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion

Exclusion Criteria

• Contra-indication to dual anti-platelet therapy.
• Ejection fraction <30%.
• Renal failure (creatinine >2 mg/dL).
• Significant co-morbidity precluding clinical follow-up.
• Acute myocardial infarction in the 48 hours prior to the procedure.
• In-stent restenosis
• Prior brachytherapy
• Thrombocytopenia <100,000
• Unprotected left main stem stenosis
• Venous or arterial grafts
• Recipient of heart transplant
• A positive pregnancy test in women with child bearing potential
• Acute infections
• Major surgery planned which will lead to discontinuation of antiplatelet therapy
• Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
• Age under 18 years old.
• There is no maximum number of lesions which can be treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVUS optimised stent implantation	IVUS optimised DES implantation	-
angiographically guided DES implantation	angiographically guided DES implantation	-

Primary Outcome Measures

Name	Time	Method
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.	Procedure day

Secondary Outcome Measures

Name	Time	Method
Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group	9 months
Major adverse cardiac events (MACE) at 9 months: superiority or statistical trend for the IVUS guided group due to lower TLR and no difference in myocardial infarction (MI) or death.	9 months
MACE events at 2 years.	2 years