Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373601
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-04
Brief Title:
SPAGO Sirolimus Paclitaxel Angiographic Gain Objective
Sponsor:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Organization:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Study Overview
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPAGO
Brief 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 200 mm and 300 mm with respect to Net Gain mm at 12 months follow-up
Detailed Description:
This is a prospective randomized multicenter no-profit and post-market study in subjects with small vessels ie at least one de novo lesion in a small vessel 200 mm and 300 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 ie no major type D E F angiographic dissections residual stenosis 30 and TIMI flow 2 the subject will be randomized in a 11 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 eg 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
Other not study lesions if applicable can be treated with any other commercial device eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None