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

ConditionDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 ~ 80 years old,

Confirmed diabetes mellitus

Indications for undergoing percutaneous coronary intervention using a drug-eluting stent (Invasive or quantitative fractional flow reserve (QFR or FFR) <0.80)

Silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction

Disqualifiers

Cardiogenic shock

Previous coronary artery bypass graft (CABG)

Left ventricular ejection fraction < 30%

Requiring oral anticoagulation medications

Trial design

Treatments tested in this trial

  • Intravascular imaging-guided PCI
  • Angiography-guided PCI group

Treatment groups

1,332 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanjing First Hospital, Nanjing Medical University

Lead sponsor

Shanxi Provincial People's Hospital

Collaborator