Status: Recruiting
SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.
Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUSUpdated: Dec 3, 2025Locations: 10
Eligibility criteria
Male or female subjects ≥18 years [+5]
Subject is a woman who is pregnant or nursing (a pregnancy test must be performe... [+22]