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

NCT06380868 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1332

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Intravascular imaging-guided PCI

Intravascular imaging including intravascular ultrasound or optical coherence tomography.

PROCEDURE

Angiography-guided PCI group

Deployment of a drug-eluting stent under angiography.

Sponsors & Collaborators

  • Shanxi Provincial People's Hospital

    collaborator OTHER_GOV

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Jing Kan, MD · Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2026-06-01
Completion
2027-07-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06380868 on ClinicalTrials.gov