Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923191
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2021-06-03
Brief Title:
The PIONEER-IV Study is Comparing Clinical Outcomes Between Angiography-derived Physiology Guidance to Usual Care in an All-comers PCI Population With Unrestrictive Use of the HT Supreme Sirolimus-eluting Stent
Sponsor:
National University of Ireland Galway Ireland
Organization:
National University of Ireland Galway Ireland
Study Overview
Official Title:
Non-inferiority of Angiography-derived Physiology Guidance Versus Usual Care in an All-comers PCI Population Treated With Unrestricted Use of the Healing-Targeted Supreme HT Supreme Drug-eluting Stent and P2Y12 Inhibitor Monotherapy After 1-month of Dual-antiplatelet Therapy
Status:
RECRUITING
Status Verified Date:
2023-10
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:
PIONEER-IV
Brief Summary:
PIONEER-IV is a prospective single-blind patient randomized 11 controlled multi-center study comparing clinical outcomes between angiography-derived physiology guidance to LRDP and usual care in an all-comers patient population including patients with high bleeding risk HBR undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent Patients will be randomized to either angio-based physiology guidance angio-FFR Quantitative Flow Ratio and coronary angiography-derived FFR caFFR or local routine diagnostic procedure LRDP and usual care Patients will be treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 21270 patients All patients both cohorts must receive dual anti-platelet therapy being aspirin ASA and ticagrelor for 1 month followed by 11 months of ticagrelor only ie monotherapy At 1 year ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator
Detailed Description:
None
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