Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380868
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-25
Brief Title:
IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus the Muticenter Randomized Prospective IVI-DIABETES Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
IVI-DIABETES
Brief Summary:
Intravascular ultrasound IVUS serves as a beneficial instrument during percutaneous coronary intervention PCI procedures affording insight into lesion characteristics and stent implantation The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent DES implantation notably ameliorated clinical outcomes in all-comers especially in patients who underwent an optimal procedure defined by IVUS as opposed to angiography guidance resonating with findings from the IVUS-XPL study OCTOBER trial and RENOVATE COMPLEX PCI trial further confirmed by more recent IVUS-ACS trial
Optical coherence tomography OCT has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI
Regrettably a dearth of prospective randomized multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus However several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus which served as the foundation for the design of this trial
Optical coherence tomography OCT has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI
Regrettably a dearth of prospective randomized multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus However several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus which served as the foundation for the design of this trial
Detailed Description:
The current study hypothesizes that IVI-guided PCI will be superior with respect to target vessel failure TVF including cardiac death target-vessel myocardial infarction TVMI or clinically-driven TVR when compared with angiography-guided PCI in patients with diabetes mellitus
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