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

Diabetes Clinical Trial

— IVI-DIABETES  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06380868
• Other study ID #: Nanjing-2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: July 20, 2027

Study information

• Verified date: April 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1332
• Est. completion date: July 20, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Procedure:
• Intravascular imaging-guided PCI
Intravascular imaging including intravascular ultrasound or optical coherence tomography.
• Angiography-guided PCI group
Deployment of a drug-eluting stent under angiography.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University	Shanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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