Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Study Overview
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Brief Summary
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The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR). These are the: Magic Touch - sirolimus coated balloon Emperor - paclitaxel and dextran coated balloon Xience - chromium-cobalt everolimus eluting stent

Official Title
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OPtimal trEatment for coroNary Drug Eluting Stent In-Stent Restenosis: Paclitaxel Versus Sirolimus Coated Balloons Versus Everolimus Eluting Stents - The OPEN ISR Study

Conditions
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Coronary Stent Restenosis

Intervention / Treatment
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* Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted for intervention of drug eluting stent restenosis Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices Optional enrollment in the optical coherence tomography sub-study (10-20% of patients) Exclusion Criteria: Patients undergoing coronary angiography after sudden cardiac death Pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: Xience chromium-cobalt everolimus eluting stent<br>The Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis. | Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis<br>* Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.<br>|
| Experimental: Emperor paclitaxel coated balloon<br>The Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis. | Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis<br>* Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.<br>|
| Experimental: Magic Touch sirolimus coated balloon<br>The Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis. | Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis<br>* Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of new onset target vessel myocardial infarction | New onset myocardial infarction that affects the target vessel treated with either study device | 6 months | 
| Occurrence of target vessel revascularization of failure | The need for further revascularization affecting the target vessel treated with either study device, or the failure of the vessel treated by either study device. | 6 months | 
| Occurrence of target lesion revascularization | The need for further revascularization of the target lesion after treatment with either study device. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage late lumen loss | Late lumen loss measured via qualitative coronary angiography in treated segment(s) | 6 months | 
| Percentage intraluminal gain after treatment | Intraluminal gain after assigned treatment measured via optical coherence tomography | index procedure | 
| Square millimetre intraluminal gain after treatment | Intraluminal gain after assigned treatment measured via optical coherence tomography | index procedure | 
| Percentage intraluminal gain after treatment | Intraluminal gain after assigned treatment measured via optical coherence tomography | 6 months | 
| Square millimeter intraluminal gain after treatment | Intraluminal gain after assigned treatment measured via optical coherence tomography | 6 months | 
| Endothelium coverage in micrometers | Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography | 6 months | 
| Late lumen loss in square millimetres | Late lumen loss in square millimetres measured via optical coherence tomography | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stent, restenosis, drug coated balloon