Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535568
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Single vs Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB
Sponsor:
None
Organization:
None
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:
No
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 11 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 20 and 40 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:
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