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
Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion
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
Age ≥ 18 years
Written informed consent
Non culprit lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery;
Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);
Non-culprit lesion involving small vessel (<3.0 mm) deemed not suitable to PCI,
Non-culprit lesion located in a bypass graft or in a grafted vessel;
Parallel
Sirolimus drug eluting ballooon therapy
DeviceNon-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.
Optimal guidelines-directed medical therapies (GDMT)
DrugOptimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques
Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up.
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.
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.
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
