Clinical trial NCT06380868: IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
Official title: Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Shanxi Provincial People's Hospital
First posted: 2024-04-24
Enrollment: 1332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will undergo 1:1 randomization to either intravascular imaging (including intravascular ultrasound or optical coherence tomography)-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group, stratified by research sites.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Rate of target vessel failure (TVF)
timeFrame: At one-year since interventions
Secondary outcomes:
measure: Rate of target vessel failure without procedure-related MI
timeFrame: At one-year since interventions
measure: Rate of cardiac death
timeFrame: At one-year since interventions
measure: Rate of all-cause death
timeFrame: At one-year since interventions
measure: Rate of procedure-related myocardial infarction (PMI)
timeFrame: Within 48 h since coronary intervention
measure: Rate of spontaneous myocardial infarction (SMI)
timeFrame: Within one-year follow-up
measure: Rate of clinically-driven revascularization
timeFrame: At one-year since coronary artery intervention
measure: Rate of stent thrombosis
timeFrame: At one-year since coronary artery intervention
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China
name: Jing Kan, MD
role: PRINCIPAL_INVESTIGATOR
References: