Clinical trial NCT06928883: Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.
Official title: TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Vulnerable Coronary Plaques
Multivessel Coronary Artery Disease
Coronary Vessel
Acute Coronary Syndromes (ACS)
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)
Lead sponsor: Cardiocentro Ticino
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up.
timeFrame: Between baseline and 6-months follow-up.
Secondary outcomes:
measure: QCA parameter (minimal lumen diameter, MLD, mm) before and after intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
measure: QCA parameter (maximal diameter stenosis, MaxS,%) before and after intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
measure: QCA parameter (reference vessel diameter, RVD, mm) before and after intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
measure: QCA parameter (lesion lenght, LL, mm) before and after intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
measure: QFR parameters before and after the intervention and at follow-up angiography
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (minimal lumen diameter, MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (minimal lumen area, MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (maximal diameter stenosis, MaxS,%) before the intervention, immediately after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (lumen volume, LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (vessel volume, VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (plaque burden, VV-LV) before the intervention, immediately after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (late lumen loss, LLL) before the intervention, immediately after the intervention and at follow-up angiography.
timeFrame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
measure: IVUS parameter (acute gain) before the intervention and immediately after the percutaneous intervention.
timeFrame: pre procedure and immediately after the procedure.
measure: IVUS parameter (disease progression) after the final result of index PCI (Tf) and at 6(±30days) month follow-up procedure.
timeFrame: immediately after the procedure and at 6(±30 days) months after the index PCI.
measure: Target Lesion Revascularization (TLR)
timeFrame: During hospitalization and at 6(±30days) month follow-up.
measure: Target Vessel Revascularization (TVR)
timeFrame: During hospitalization and at 6(±30days) month follow-up.
measure: Target Vessel Failure (TVF)
timeFrame: During hospitalization and at 6(±30days) month follow-up.
measure: Individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)
timeFrame: During hospitalization and at 6(±30days) month follow-up.
measure: Major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization.
timeFrame: 6(± 30 days) months after the index PCI.
measure: The individual components of the composite major adverse cardiac events (MACE- defined as cardiac death, any myocardial infarction and any revascularization).
timeFrame: 6(± 30 days) months after the index PCI.
measure: Stroke
timeFrame: 6(± 30 days) months after the index PCI.
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino - EOC
Study officials:
References: