Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 5:53 AM
Study NCT ID:
NCT06535568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB
Sponsor:
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Organization:
Study Overview
Official Title:
International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons
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:
PICCOLETO IV
Brief Summary:
International multicenter, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the rate of ischemic and bleeding adverse events of a single antiplatelet regimen (SAPT) since the time of PCI with latest generation DCB in elderly or HBR population with stable or unstable coronary syndromes.
Detailed Description:
The purpose of PICCOLETO IV study is to observe and evaluate the efficacy and safety of a single antiplatelet therapy (SAPT) after successful DCB angioplasty with Essential Pro (Drug-coated balloon (iVascular) in native coronary artery disease in vessels with diameter \>=2.0 and \<=4.0 mm as compared to the routine dual antiplatelet therapy (DAPT). Patients with stable or unstable coronary syndromes will be enrolled in this study.
Study Oversight
Has Oversight DMC:
True
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?: