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The goal of this pilot clinical trial is to evaluate the use of the Selution SLR sirolimus-eluting balloon, in addition to guideline-directed medical therapy (GDMT), for the preventive treatment of non-flow-limiting vulnerable coronary lesions, compared to GDMT alone, in adult patients with multivessel coronary artery disease and a recent acute coronary syndrome (within 90 days).
The main research question is:
Does the use of the Selution SLR sirolimus-eluting balloon in combination with GDMT reduce the progression and vulnerability of non-flow-limiting vulnerable coronary plaques?
Participants will undergo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy | Experimental | Selution SLR sirolimus-eluting balloon additional to guidelines-directed medical therapy for the preventive treatment of non-flow limiting vulnerable coronary lesions |
|
| Guidelines-directed medical therapy | Active Comparator | Guidelines-directed medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus drug eluting ballooon therapy | Device | Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up. | Between baseline and 6-months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| QCA parameter (minimal lumen diameter, MLD, mm) before and after intervention and at follow-up angiography. | Minimal lumen diameter (MLD, mm) before the intervention, immediately after the intervention and at follow up angiography. | pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. |
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Inclusion Criteria:
Potential subjects must fulfill all following inclusion criteria:
Exclusion Criteria:
Patients are not eligible if any of the following applies:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Valgimigli Marco Valgimigli, MD, PhD | Contact | +41 (0) 91 811 51 11 | marco.valgimigli@eoc.ch | |
| Enrico Frigoli Frigoli, MD, MHS | Contact | +41 (0) 91 811 51 11 | enricofrigoli@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Cardiocentro Ticino - EOC | Lugano | 6900 | Switzerland |
The final study data will be disseminated to the scientific community through the publication of results in peer-reviewed journals, ensuring accessibility to researchers and healthcare professionals.
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|
| Optimal guidelines-directed medical therapies (GDMT) | Drug | Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques |
|
| QCA parameter (maximal diameter stenosis, MaxS,%) before and after intervention and at follow-up angiography. |
Maximal diameter stenosis (MaxS,%) before the intervention, immediately after the intervention and at follow up angiography. |
| pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. |
| QCA parameter (reference vessel diameter, RVD, mm) before and after intervention and at follow-up angiography. | Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow up angiography. | pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. |
| QCA parameter (lesion lenght, LL, mm) before and after intervention and at follow-up angiography. | Lesion lenght (LL, mm) before the intervention, immediately after the intervention and at follow up angiography. | pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. |
| QFR parameters before and after the intervention and at follow-up angiography | Quantitative Flow Ration (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (minimal lumen diameter, MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography. | Minimal lumen diameter (MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (minimal lumen area, MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography. | Minimal lumen area (MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (maximal diameter stenosis, MaxS,%) before the intervention, immediately after the intervention and at follow-up angiography. | Maximal diameter stenosis (MaxS, %) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (lumen volume, LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. | Lumen volume (LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (vessel volume, VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. | Vessel volume (VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (plaque burden, VV-LV) before the intervention, immediately after the intervention and at follow-up angiography. | Plaque burden (VV-LV) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (late lumen loss, LLL) before the intervention, immediately after the intervention and at follow-up angiography. | Late lumen loss (LLL) before the intervention, immediately after the intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. |
| IVUS parameter (acute gain) before the intervention and immediately after the percutaneous intervention. | Acute gain before the intervention (T0) and immediately after the percutaneous intervention (Tf). | pre procedure and immediately after the procedure. |
| IVUS parameter (disease progression) after the final result of index PCI (Tf) and at 6(±30days) month follow-up procedure. | Variation between the final result of index PCI (Tf) and procedure at 6(±30days) month follow-up (Tc). | immediately after the procedure and at 6(±30 days) months after the index PCI. |
| Target Lesion Revascularization (TLR) | Rate of target lesion revascularization (TLR) defined as urgent and non urgent | During hospitalization and at 6(±30days) month follow-up. |
| Target Vessel Revascularization (TVR) | Rate of target vessel revascularization (TVR) defined as urgent and non-urgent. | During hospitalization and at 6(±30days) month follow-up. |
| Target Vessel Failure (TVF) | Rate of target vessel failure, defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization. | During hospitalization and at 6(±30days) month follow-up. |
| Individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization) | Rate of the individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization). | During hospitalization and at 6(±30days) month follow-up. |
| Major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization. | Rate of major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization . | 6(± 30 days) months after the index PCI. |
| The individual components of the composite major adverse cardiac events (MACE- defined as cardiac death, any myocardial infarction and any revascularization). | Rate of the individual components of the composite MACE endpoint (defined as cardiac death, any myocardial infarction, any revascularization). | 6(± 30 days) months after the index PCI. |
| Stroke | Rate of stroke. | 6(± 30 days) months after the index PCI. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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