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

NCT06928883 | Not Yet Recruiting

• 1 other identifier: TITAN-PARADISE Pilot
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• QCA parameter (minimal lumen diameter, MLD, mm) before and after 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.

  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.

  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.

  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

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

Study Arms (2)

Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy

EXPERIMENTAL

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

Guidelines-directed medical therapy

ACTIVE COMPARATOR

Guidelines-directed medical therapy

Drug: Optimal guidelines-directed medical therapies (GDMT)

Interventions

Sirolimus drug eluting ballooon therapy DEVICE

Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.

Also known as: DEB-GDMT

Sirolimus-eluting DEB (Selution SLR) therapy + 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

Guidelines-directed medical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients are not eligible if any of the following applies:
• 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;
• Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment;
• Known pregnancy r breast-feeding patients;
• Life expectancy \<2 year due to other severe non-cardiac disease;
• Legally incompetent to provide informed consent;
• Partecipation in another clinical study with an investigational product

Sponsors & Collaborators

• Cardiocentro Ticino: lead

Study Sites (1)

Istituto Cardiocentro Ticino - EOC

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Marco Valgimigli Marco Valgimigli, MD, PhD

CONTACT

+41 (0) 91 811 51 11; marco.valgimigli@eoc.ch

Enrico Frigoli Frigoli, MD, MHS

CONTACT

+41 (0) 91 811 51 11; enricofrigoli@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Med. Marco Valgimigli, Deputy Chief

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 15, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)