Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.

N/ANot Yet RecruitingNCT06928883

Cardiocentro Ticino24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Arterial Disease (CAD)Vulnerable Coronary Plaques Multivessel Coronary Artery Disease

Interventions

Sirolimus drug eluting ballooon therapyDEVICE

Non-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)DRUG

Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up.

Time frame: Between baseline and 6-months follow-up.

Secondary Outcomes

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.

Time frame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.