Angiography Versus (vs) IVUS Optimisation

Study Overview
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Brief Summary
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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

Official Title
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Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: IVUS optimised DES implantation
* Procedure: angiographically guided DES implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS optimised stent implantation<br> | Procedure: IVUS optimised DES implantation<br>* Ivus optimised stent implantation<br>|
| Active Comparator: angiographically guided DES implantation<br> | Procedure: angiographically guided DES implantation<br>* angiographically guided DES implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group. |  | Procedure day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with at least one complex lesion suitable for implantation of a drug-eluting stent