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

NCT ID: NCT06928883

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2028-12-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sirolimus drug eluting ballooon therapy

Intervention Type: DEVICE

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

Guidelines-directed medical therapy

Guidelines-directed medical therapy

Group Type: ACTIVE_COMPARATOR

Optimal guidelines-directed medical therapies (GDMT)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

Optimal guidelines-directed medical therapies (GDMT)

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

Intervention Type: DRUG

Other Intervention Names

DEB-GDMT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiocentro Ticino

OTHER

Sponsor Role: lead

Responsible Party

Marco Valgimigli

Prof. Dr. Med. Marco Valgimigli, Deputy Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istituto Cardiocentro Ticino - EOC

Lugano, , Switzerland

Countries

Switzerland

Central Contacts

Marco Valgimigli Marco Valgimigli, MD, PhD

Role: CONTACT

marco.valgimigli@eoc.ch

+41 (0) 91 811 51 11

Enrico Frigoli Frigoli, MD, MHS

Role: CONTACT

enricofrigoli@eoc.ch

+41 (0) 91 811 51 11

Facility Contacts

Enrico Frigoli, MD, MHS

Role: primary

enrico.frigoli@eoc.ch

+41 (0) 91 811 51 11

Other Identifiers

TITAN-PARADISE Pilot

Identifier Type: -

Identifier Source: org_study_id