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

TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)

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 Overview

• Status: Not yet recruiting
• Conditions: Multivessel Coronary Artery Disease; Coronary Vessel; Acute Coronary Syndromes (ACS); Vulnerable Coronary Plaques; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Device: Sirolimus drug eluting ballooon therapy; Drug: Optimal guidelines-directed medical therapies (GDMT)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Valgimigli Marco Valgimigli, MD, PhD; Phone Number: +41 (0) 91 811 51 11; Email: marco.valgimigli@eoc.ch
• Study Contact Backup: Name: Enrico Frigoli Frigoli, MD, MHS; Phone Number: +41 (0) 91 811 51 11; Email: enricofrigoli@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Istituto Cardiocentro Ticino - EOC
    • Contact: Enrico Frigoli, MD, MHS; Phone Number: +41 (0) 91 811 51 11; Email: enrico.frigoli@eoc.ch
    • Contact: Marco Valgimigli, Md, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy; Selution SLR sirolimus-eluting balloon additional to guidelines-directed medical therapy for the preventive treatment of non-flow limiting vulnerable coronary lesions	Device: Sirolimus drug eluting ballooon therapy; Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.; Other Names: DEB-GDMT
Active Comparator: Guidelines-directed medical therapy	Drug: Optimal guidelines-directed medical therapies (GDMT); Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (minimal lumen diameter, MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography.	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.
IVUS parameter (minimal lumen area, MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography.	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.
IVUS parameter (maximal diameter stenosis, MaxS,%) before the intervention, immediately after the intervention and at follow-up angiography.	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.
IVUS parameter (lumen volume, LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.	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.
IVUS parameter (vessel volume, VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.	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.
IVUS parameter (plaque burden, VV-LV) before the intervention, immediately after the intervention and at follow-up angiography.	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.
IVUS parameter (late lumen loss, LLL) before the intervention, immediately after the intervention and at follow-up angiography.	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.
IVUS parameter (acute gain) before the intervention and immediately after the percutaneous intervention.	Acute gain before the intervention (T0) and immediately after the percutaneous intervention (Tf).	pre procedure and immediately after the procedure.
IVUS parameter (disease progression) after the final result of index PCI (Tf) and at 6(±30days) month follow-up procedure.	Variation between the final result of index PCI (Tf) and procedure at 6(±30days) month follow-up (Tc).	immediately after the procedure and at 6(±30 days) months after the index PCI.
Target Lesion Revascularization (TLR)	Rate of target lesion revascularization (TLR) defined as urgent and non urgent	During hospitalization and at 6(±30days) month follow-up.
Target Vessel Revascularization (TVR)	Rate of target vessel revascularization (TVR) defined as urgent and non-urgent.	During hospitalization and at 6(±30days) month follow-up.
Target Vessel Failure (TVF)	Rate of target vessel failure, defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization.	During hospitalization and at 6(±30days) month follow-up.
Individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)	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).	During hospitalization and at 6(±30days) month follow-up.
Major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization.	Rate of major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization .	6(± 30 days) months after the index PCI.
The individual components of the composite major adverse cardiac events (MACE- defined as cardiac death, any myocardial infarction and any revascularization).	Rate of the individual components of the composite MACE endpoint (defined as cardiac death, any myocardial infarction, any revascularization).	6(± 30 days) months after the index PCI.
Stroke	Rate of stroke.	6(± 30 days) months after the index PCI.

Collaborators and Investigators

• Sponsor: Cardiocentro Ticino

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Multivessel coronary artery disease; Acute Coronary Syndromes (ACS); Coronary Arterial Disease (CAD); Vulnerable Coronary Plaques; Coronary vessel; 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)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Sirolimus
• Other Study ID Numbers: TITAN-PARADISE Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The final study data will be disseminated to the scientific community through the publication of results in peer-reviewed journals, ensuring accessibility to researchers and healthcare professionals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No