Status:
NOT_YET_RECRUITING
Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.
Lead Sponsor:
Cardiocentro Ticino
Conditions:
Coronary Arterial Disease (CAD)
Vulnerable Coronary Plaques
Eligibility:
All Genders
18+ years
Phase:
NA
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 no...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06928883
Start Date
April 1 2025
End Date
December 31 2028
Last Update
April 15 2025
Active Locations (1)
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1
Istituto Cardiocentro Ticino - EOC
Lugano, Switzerland, 6900