IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravascular imaging-guided PCI, Angiography-guided PCI group.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
Overview
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.
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.
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.
Primary outcome measures
- Rate of target vessel failure (TVF) [Time frame: At one-year since interventions]
Secondary outcome measures (7)
- Rate of target vessel failure without procedure-related MI [Time frame: At one-year since interventions]
- Rate of cardiac death [Time frame: At one-year since interventions]
- Rate of all-cause death [Time frame: At one-year since interventions]
- Rate of procedure-related myocardial infarction (PMI) [Time frame: Within 48 h since coronary intervention]
- Rate of spontaneous myocardial infarction (SMI) [Time frame: Within one-year follow-up]
- Rate of clinically-driven revascularization [Time frame: At one-year since coronary artery intervention]
- Rate of stent thrombosis [Time frame: At one-year since coronary artery intervention]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Nanjing First Hospital — Nanjing
Publications
- Gao XF, Kan J, Wu HY, Chen J, Chen X, Wen SY, Gong YT, Tong Q, Luo J, Shao YB, Gill BUA, Malik FTN, Santoso T, Daggubati R, Rodriguez AE, Francesco L, Rahman A, Sheiban I, Kedev S, Munawar M, Kwan TW, Wang Y, Ye F, Zhang JJ, Shou XL, Chen SL; IVI-DIABETES investigators. Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention in patients with diabetes mellitus: Rat PMID 39914556
Identifiers
NCT: NCT06380868 · Nanjing-2