Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551662
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
DCB vs DES in Bifurcation Coronary Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Drug-coated Balloons vs Drug Eluting Stents in Bifurcation Coronary Lesions PICCOLETO V Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICCOLETO V
Brief Summary:
This is an investigator-driven prospective multicentric international randomized clinical study in an open-label randomized fashion where patients with bifurcation coronary artery disease Medina 111101011001 in vessels with diameter 20 visual estimation and with a clinical indication to PCI will be enrolled After successful predilatation with any tool deemed useful patients will be randomized 111 to SCB PCB or standard treatment with DES for bifurcation native vessel disease All patients with a clinical indication for PCI both stable coronary artery disease and acute coronary syndrome will be enrolled
Before participating all the candidates will be clearly informed about the study including the possible risks and benefits and will be asked to provide a written informed consent Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria or that may have at least one exclusion criteria and then be excluded from the study screening failure even after informed consent is obtained
Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria will participate to the study After randomization the procedure will consist in standard coronary angioplasty following international guidelinesconsensus documents and as per local practice If the patient has been randomized to SCB or PCB it is mandatory to adequately prepare the lesion
Before participating all the candidates will be clearly informed about the study including the possible risks and benefits and will be asked to provide a written informed consent Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria or that may have at least one exclusion criteria and then be excluded from the study screening failure even after informed consent is obtained
Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria will participate to the study After randomization the procedure will consist in standard coronary angioplasty following international guidelinesconsensus documents and as per local practice If the patient has been randomized to SCB or PCB it is mandatory to adequately prepare the lesion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None