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NCT06380868Enrolling by invitation

IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus

Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
Nanjing First Hospital, Nanjing Medical UniversityClinicalTrials.govprocedure
Verified
Study focus
Disease/Condition
Diabetes
Drug/Device/Intervention
Intravascular imaging-guided PCI
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Nanjing First Hospital, Nanjing Medical University
Location
Nanjing, China
Timeline & enrollment
Phase
N/A
Start date
Jun 10, 2024
End date
Jul 20, 2027
Enrollment
1332 participants
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
Diabetes mellitusUnspecified diabetes mellitusOther specified diabetes mellitusUnspecified diabetes mellitus without complicationsOther specified diabetes mellitus without complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06380868
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.