IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus - Trial NCT06380868
Access comprehensive clinical trial information for NCT06380868 through Pure Global AI's free database. This phase not specified trial is sponsored by Nanjing First Hospital, Nanjing Medical University and is currently Enrolling by invitation. The study focuses on Diabetes. Target enrollment is 1332 participants.
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Study Focus
Sponsor & Location
Nanjing First Hospital, Nanjing Medical University
Timeline & Enrollment
N/A
Jun 10, 2024
Jul 20, 2027
Primary Outcome
Rate of target vessel failure (TVF)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06380868
Non-Device Trial