SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective — SPAGO  

Coronary Artery Disease Clinical Trial

Official title: Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.

Status Not yet recruiting

Clinical Trial Summary

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) at 12 months follow-up.

Clinical Trial Description

This is a prospective, randomized, multicenter, no-profit and post-market study in subjects with small vessels, i.e. at least one de novo lesion in a small vessel (>2.00 mm and ≤3.00). Vessel size is evaluated by visual estimation. It is possible to include more than one study lesion even if they are located in the same vessel. In case of a successful pre-dilatation (i.e. no major (type D, E, F) angiographic dissections, residual stenosis ≤ 30% and TIMI flow ≥ 2), the subject will be randomized in a 1:1 fashion to Selution or SeQuent Please Neo. If the Investigator decides to include more than one study lesion for the same subject, all the lesions must be successful pre-dilatated and must be treated following the assigned treatment by randomization.

Other not study lesions (if applicable) can be treated with any other commercial device (e.g. drug-eluting stent). All not study lesions should be treated prior to study target lesion procedure, and should be successful and uncomplicated.

Follow-up by phone call will occur at 1 and 6 months post-PCI. At 12 months all subjects will perform an angiographic follow up at the same site where the index procedure was performed. Quantitative Coronary Angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and on follow up angiography by the imaging core lab.

All subjects must receive dual anti-platelet therapy (DAPT), being aspirin (ASA) and P2Y12 inhibition therapy for at least 1 month after drug coated balloon PCI or according to standard local practice (with the choice of agent left to the discretion of the investigator), followed by ASA monotherapy indefinitely. However, in case the subject had recent ACS or is receiving additional drug-eluting stents, DAPT must be given according to local standard of care. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Lesion
• Coronary Stenosis
• Percutaneous Coronary Intervention

• NCT number: NCT06373601
• Study type: Interventional
• Source: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
• Contact: Marina Cornacchia Schenetti
• Phone: 03761810406
• Email: schema1950@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Completion date: February 1, 2027