IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus (IVI-DIABETES)

May 15, 2026 updated by: Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The current study hypothesizes that IVI-guided PCI will be superior with respect to target vessel failure (TVF), including cardiac death, target-vessel myocardial infarction (TVMI), or clinically-driven TVR when compared with angiography-guided PCI in patients with diabetes mellitus.

Study Type

Interventional

Enrollment (Estimated)

1332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shao-Liang C Chen, MD
  • Phone Number: 13605157029
  • Email: chmengx@126.com

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Contact:
          • Shuli M Zhao, MD
          • Phone Number: +86-25-52271003
          • Email: shuliz@126.com
        • Contact:
        • Principal Investigator:
          • Jun-Jie M Zhang, PhD
        • Sub-Investigator:
          • Fei M Ye, MD
        • Sub-Investigator:
          • Ling F Lin, MD
        • Sub-Investigator:
          • Yue F Gu, PhD
        • Sub-Investigator:
          • Wenying F Zhou, PhD
        • Principal Investigator:
          • Jing F Kan, MBBS
        • Sub-Investigator:
          • Jinque F Luo, PhD
        • Principal Investigator:
          • Zhen M Ge, MD
        • Principal Investigator:
          • Xiaobo M Li, MD
        • Principal Investigator:
          • Xiaofei M Gao, MD
        • Sub-Investigator:
          • Xiangquan M Kong, MD
        • Sub-Investigator:
          • Minghui F Li, PhD
        • Principal Investigator:
          • Juan F Zhang, MD
        • Principal Investigator:
          • Linlin F Zhu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 ~ 80 years old,
  2. Confirmed diabetes mellitus
  3. Indications for undergoing percutaneous coronary intervention using a drug-eluting stent (Invasive or quantitative fractional flow reserve (QFR or FFR) <0.80)
  4. Silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction

Exclusion Criteria:

  1. Cardiogenic shock
  2. Previous coronary artery bypass graft (CABG)
  3. Left ventricular ejection fraction < 30%
  4. Requiring oral anticoagulation medications
  5. Any planned surgery within 12 months
  6. Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2
  7. Platelet count < 100,000 mm3
  8. Contraindication to study medications or metal
  9. Women of childbearing potential
  10. Life expectancy < 1 year
  11. Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravascular imaging-guided PCI group
For patients in this group, intravascular imaging will be encouraged to performed prior-to and post-coronary intervention using new generation drug-eluting stents
Procedure: Intravascular imaging-guided PCI
Intravascular imaging including intravascular ultrasound or optical coherence tomography.
Active Comparator: Angiography-guided PCI group
For patients in this group, implantation of a new generation drug-eluting stent will be guided by angiography only. Unless coronary artery lesion is complex or ambiguous, intravascular imaging is not allowed to be used. If intravascular imaging is used because of the reason mentioned above, post-stenting assessment is absolutely not allowed.
Procedure: Angiography-guided PCI group
Deployment of a drug-eluting stent under angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of target vessel failure (TVF)
Time Frame: At one-year since interventions
TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization
At one-year since interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of target vessel failure without procedure-related MI
Time Frame: At one-year since interventions
Procedural-related myocardial infarction (PMI) would be excluded from the calculation of TVF
At one-year since interventions
Rate of cardiac death
Time Frame: At one-year since interventions
Any death without clear reasons
At one-year since interventions
Rate of all-cause death
Time Frame: At one-year since interventions
Any death occurs within one-year follow-up
At one-year since interventions
Rate of procedure-related myocardial infarction (PMI)
Time Frame: Within 48 h since coronary intervention
48 hours after coronary intervention
Within 48 h since coronary intervention
Rate of spontaneous myocardial infarction (SMI)
Time Frame: Within one-year follow-up
MI happens between 48 h and one-year since coronary intervention
Within one-year follow-up
Rate of clinically-driven revascularization
Time Frame: At one-year since coronary artery intervention
Target vessel revascularization was defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, which included upstream and downstream branches and the target lesion itself.
At one-year since coronary artery intervention
Rate of stent thrombosis
Time Frame: At one-year since coronary artery intervention
Definite or probable stent thrombosis
At one-year since coronary artery intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Collaborators

Shanxi Provincial People's Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 20, 2027

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nanjing-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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