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

Launched by CARDIOCENTRO TICINO · Apr 8, 2025

Keywords

ClinConnect Summary

The Ticin Pilot Study is a clinical trial that aims to explore a new treatment option for patients with coronary artery disease (CAD), especially those who have had a recent heart issue, known as acute coronary syndrome (ACS). The study is looking at a special type of balloon called the Selution SLR sirolimus-eluting balloon, which is used during a procedure to help treat specific vulnerable areas in the heart's blood vessels. These areas, while not currently causing blockages, could become problematic in the future. The trial will compare the effects of this balloon treatment combined with standard medical care against standard medical care alone to see if it helps reduce the risk of these vulnerable areas worsening.

To be eligible for the study, participants need to be at least 18 years old, have multivessel coronary artery disease, and have experienced an ACS within the past 90 days. They must also have certain non-dangerous lesions in their heart vessels that can be treated. If enrolled, participants will undergo a procedure where their heart will be examined using specialized imaging techniques, and they will have follow-up tests and check-ins over the next two years to monitor their heart health. This study is not yet recruiting participants, but it offers a chance to be part of research that could lead to better treatments for heart disease in the future.

Gender

ALL

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