Sirolimus balloon test for fragile heart artery plaques
Tests a sirolimus-releasing balloon with standard medicine in adults with recent heart attack.
Plain-language title generated from the registry record
Registry title: Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.
Key facts
- Where
- Lugano, SwitzerlandSee the site
Where in Switzerland
- Istituto Cardiocentro Ticino - EOCLugano, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cardiocentro Ticino
- Trial code
- NCT06928883
- Record updated
- 15 April 2025
- Original description
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).Read full original descriptionShow less
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
Inclusion: Potential subjects must fulfill all following inclusion criteria:; Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion; 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.
Exclusion: Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent); Partecipation in another clinical study with an investigational product; Life expectancy <2 year due to other severe non-cardiac disease; Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment; 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 involving small vessel (<3.0 mm) deemed not suitable to PCI,; Non-culprit lesion located in a bypass graft or in a grafted vessel; Known pregnancy r breast-feeding patients; Legally incompetent to provide informed consent.