NOT YET RECRUITING
NCT06928883
Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.
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
Gender: All
Ages: 18 Years - Any
Coronary Arterial Disease (CAD)
Vulnerable Coronary Plaques
Multivessel Coronary Artery Disease
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