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NCT Number: NCT06380868

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location status: Recruiting

Location contact

Fei M Ye, MD

SUB_INVESTIGATOR

Jing F Kan, MBBS

PRINCIPAL_INVESTIGATOR

Jinque F Luo, PhD

SUB_INVESTIGATOR

Juan F Zhang, MD

PRINCIPAL_INVESTIGATOR

Jun-Jie M Zhang, PhD

PRINCIPAL_INVESTIGATOR

Ling F Lin, MD

CONTACT

[email protected]

+86-25-52271--9

Ling F Lin, MD

SUB_INVESTIGATOR

Linlin F Zhu, MD

PRINCIPAL_INVESTIGATOR

Minghui F Li, PhD

SUB_INVESTIGATOR

Shuli M Zhao, MD

CONTACT

[email protected]

+86-25-52271003

Wenying F Zhou, PhD

SUB_INVESTIGATOR

Xiangquan M Kong, MD

SUB_INVESTIGATOR

Xiaobo M Li, MD

PRINCIPAL_INVESTIGATOR

Xiaofei M Gao, MD

PRINCIPAL_INVESTIGATOR

Yue F Gu, PhD

SUB_INVESTIGATOR

Zhen M Ge, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Cardiogenic shock
  • Previous coronary artery bypass graft (CABG)
  • Left ventricular ejection fraction < 30%
  • Requiring oral anticoagulation medications
  • Any planned surgery within 12 months
  • Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2
  • Platelet count < 100,000 mm3
  • Contraindication to study medications or metal
  • Women of childbearing potential
  • Life expectancy < 1 year
  • 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.)

Treatment and study plan

Intravascular imaging-guided PCI

Procedure

Intravascular imaging including intravascular ultrasound or optical coherence tomography.

Angiography-guided PCI group

Procedure

Deployment of a drug-eluting stent under angiography.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Rate of cardiac death

    Time frame: At one-year since interventions

    Any death without clear reasons

  3. Rate of all-cause death

    Time frame: At one-year since interventions

    Any death occurs within one-year follow-up

  4. Rate of procedure-related myocardial infarction (PMI)

    Time frame: Within 48 h since coronary intervention

    48 hours after coronary intervention

  5. Rate of spontaneous myocardial infarction (SMI)

    Time frame: Within one-year follow-up

    MI happens between 48 h and one-year since coronary intervention

  6. 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.

  7. Rate of stent thrombosis

    Time frame: At one-year since coronary artery intervention

    Definite or probable stent thrombosis

Study contacts

Contact information is provided by the study sponsor or research team.

Shao-Liang C Chen, MD

CONTACT

[email protected]

13605157029

Xiling Shou, MD

CONTACT

[email protected]

+8618966700335

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Collaborators

  • Shanxi Provincial People's Hospital

Registry information

Official study title

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

Acronym: IVI-DIABETES

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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