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

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: Procedure: Intravascular imaging-guided PCI; Procedure: Angiography-guided PCI group

• Registration Number: NCT06380868
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-24
• Study Start: 2024-07-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-06-01
• Study Completion: 2027-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1332

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravascular imaging-guided PCI group	Intravascular imaging-guided PCI	For patients in this group, intravascular imaging will be encouraged to performed prior-to and post-coronary intervention using new generation drug-eluting stents
Angiography-guided PCI group	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.

Primary Outcome Measures

Name	Time	Method
Rate of target vessel failure (TVF)	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 Outcome Measures

Name	Time	Method
Rate of target vessel failure without procedure-related MI	At one-year since interventions	Procedural-related myocardial infarction (PMI) would be excluded from the calculation of TVF
Rate of procedure-related myocardial infarction (PMI)	Within 48 h since coronary intervention	48 hours after coronary intervention
Rate of cardiac death	At one-year since interventions	Any death without clear reasons
Rate of all-cause death	At one-year since interventions	Any death occurs within one-year follow-up
Rate of spontaneous myocardial infarction (SMI)	Within one-year follow-up	MI happens between 48 h and one-year since coronary intervention
Rate of clinically-driven revascularization	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.
Rate of stent thrombosis	At one-year since coronary artery intervention	Definite or probable stent thrombosis

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China