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IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
Sponsor: Nanjing First Hospital, Nanjing Medical University
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.
Official title: Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1332
Start Date
2024-07-17
Completion Date
2027-07-20
Last Updated
2025-03-14
Healthy Volunteers
No
Conditions
Interventions
Intravascular imaging-guided PCI
Intravascular imaging including intravascular ultrasound or optical coherence tomography.
Angiography-guided PCI group
Deployment of a drug-eluting stent under angiography.
Locations (1)
Nanjing First Hospital
Nanjing, Jiangsu, China