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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xience chromium-cobalt everolimus eluting stent | Active Comparator | The Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis. |
|
| Emperor paclitaxel coated balloon | Experimental | The Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis. |
|
| Magic Touch sirolimus coated balloon | Experimental | The Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular management of prior implanted coronary drug eluting stent restenosis | Procedure | Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| István F Édes, MD PhD | Semmelweis University Heart and Vascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Heart and Vascular Center | Budapest | Budapest | 1122 | Hungary | ||
| University of Szeged, Department of Invasive Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35694680 | Background | Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022. | |
| 39997337 |
| Label | URL |
|---|---|
| Link to design and feasibility manuscript | View source |
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| 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 |
| Szeged |
| Csongád-Csanád |
| 6725 |
| Hungary |
| Kulyassa PM, Nemeth BT, Hizoh I, Janko LK, Ruzsa Z, Jambrik Z, Balazs BB, Becker D, Merkely B, Edes IF. The Design and Feasibility of Optimal Treatment for Coronary Drug-Eluting Stent In-Stent Restenosis (OPEN-ISR)-A Prospective, Randomised, Multicentre Clinical Trial. J Pers Med. 2025 Feb 2;15(2):60. doi: 10.3390/jpm15020060. |