Acute Coronary Syndromes (ACS), Coronary Arterial Disease (CAD), Coronary Vessel, Multivessel Coronary Artery Disease, Vulnerable Coronary Plaques
Conditions
Keywords
Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Multivessel coronary artery disease, Coronary vessel, Acute Coronary Syndromes (ACS), Non-flow limiting vulnerable coronary plaques, Sirolimus-eluting DEB, DEB Selution SLR, Guidelines-directed medical therapies (GDMT), IVUS-NIRS, MaxLCBI4mm, MaxLCBI4mm≥325, Lipid Core Burden Index (LCBI)
Brief summary
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 * PCI procedure with baseline IVUS-NIRS assessment * Follow-up coronary angiography at 6 months with IVUS-NIRS assessment * Clinical follow-up at 3, 6, and 24 months after study enrollment
Interventions
DEVICESirolimus drug eluting ballooon therapy
Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.
DRUGOptimal guidelines-directed medical therapies (GDMT)
Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques
Sponsors
Cardiocentro Ticino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Potential subjects must fulfill all following inclusion criteria: 1. Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion 2. Presence of ≥ 2 de novo non-culprit lesion without hemodynamic relevance in two different coronary vessels (demonstrated either by wire-based or angiography-based coronary physiology) and with MaxLCBI4mm ≥ 325 at baseline IVUS-NIRS 3. Age ≥ 18 years 4. Written informed consent
Exclusion criteria
Patients are not eligible if any of the following applies: 1. Non culprit lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery; 2. Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent); 3. Non-culprit lesion involving small vessel (\<3.0 mm) deemed not suitable to PCI, 4. Non-culprit lesion located in a bypass graft or in a grafted vessel; 5. Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment; 6. Known pregnancy r breast-feeding patients; 7. Life expectancy \<2 year due to other severe non-cardiac disease; 8. Legally incompetent to provide informed consent; 9. Partecipation in another clinical study with an investigational product
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QCA parameter (maximal diameter stenosis, MaxS,%) before and after intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. | Maximal diameter stenosis (MaxS,%) before the intervention, immediately after the intervention and at follow up angiography. |
| QCA parameter (reference vessel diameter, RVD, mm) before and after intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. | Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow up angiography. |
| QCA parameter (lesion lenght, LL, mm) before and after intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. | Lesion lenght (LL, mm) before the intervention, immediately after the intervention and at follow up angiography. |
| QFR parameters before and after the intervention and at follow-up angiography | pre procedure, immediately after the procedure and at 6(±30days) months follow-up. | Quantitative Flow Ration (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography. |
| IVUS parameter (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. | Minimal lumen diameter (MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography. |
| IVUS parameter (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. | Minimal lumen area (MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography. |
| IVUS parameter (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. | Maximal diameter stenosis (MaxS, %) before the intervention, immediately after the intervention and at follow-up angiography. |
| IVUS parameter (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. | Lumen volume (LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. |
| IVUS parameter (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. | Vessel volume (VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography. |
| IVUS parameter (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. | Plaque burden (VV-LV) before the intervention, immediately after the intervention and at follow-up angiography. |
| QCA parameter (minimal lumen diameter, MLD, mm) before and after intervention and at follow-up angiography. | pre procedure, immediately after the procedure and at 6(±30 days) months follow-up. | Minimal lumen diameter (MLD, mm) before the intervention, immediately after the intervention and at follow up angiography. |
| IVUS parameter (acute gain) before the intervention and immediately after the percutaneous intervention. | pre procedure and immediately after the procedure. | Acute gain before the intervention (T0) and immediately after the percutaneous intervention (Tf). |
| IVUS parameter (disease progression) after the final result of index PCI (Tf) and at 6(±30days) month follow-up procedure. | immediately after the procedure and at 6(±30 days) months after the index PCI. | Variation between the final result of index PCI (Tf) and procedure at 6(±30days) month follow-up (Tc). |
| Target Lesion Revascularization (TLR) | During hospitalization and at 6(±30days) month follow-up. | Rate of target lesion revascularization (TLR) defined as urgent and non urgent |
| Target Vessel Revascularization (TVR) | During hospitalization and at 6(±30days) month follow-up. | Rate of target vessel revascularization (TVR) defined as urgent and non-urgent. |
| Target Vessel Failure (TVF) | During hospitalization and at 6(±30days) month follow-up. | Rate of target vessel failure, defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization. |
| 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. | 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). |
| Major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization. | 6(± 30 days) months after the index PCI. | Rate of major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization . |
| The individual components of the composite major adverse cardiac events (MACE- defined as cardiac death, any myocardial infarction and any revascularization). | 6(± 30 days) months after the index PCI. | Rate of the individual components of the composite MACE endpoint (defined as cardiac death, any myocardial infarction, any revascularization). |
| Stroke | 6(± 30 days) months after the index PCI. | Rate of stroke. |
| IVUS parameter (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. | Late lumen loss (LLL) before the intervention, immediately after the intervention and at follow-up angiography. |
Countries
Switzerland
Contacts
Primary ContactMarco Valgimigli Marco Valgimigli, MD, PhD
Backup ContactEnrico Frigoli Frigoli, MD, MHS
Outcome results
None listed