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

NCT ID: NCT06380868

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2027-07-20

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intravascular imaging-guided PCI group

For patients in this group, intravascular imaging will be encouraged to performed prior-to and post-coronary intervention using new generation drug-eluting stents

Group Type: EXPERIMENTAL

Intravascular imaging-guided PCI

Intervention Type: PROCEDURE

Intravascular imaging including intravascular ultrasound or optical coherence tomography.

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.

Group Type: ACTIVE_COMPARATOR

Angiography-guided PCI group

Intervention Type: PROCEDURE

Deployment of a drug-eluting stent under angiography.

Interventions

Intravascular imaging-guided PCI

Intravascular imaging including intravascular ultrasound or optical coherence tomography.

Intervention Type: PROCEDURE

Angiography-guided PCI group

Deployment of a drug-eluting stent under angiography.

Intervention Type: PROCEDURE

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanxi Provincial People's Hospital

OTHER_GOV

Sponsor Role: collaborator

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shaoliang Chen, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Kan, MD

Role: PRINCIPAL_INVESTIGATOR

Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shao-Liang C Chen, MD

Role: CONTACT

chmengx@126.com

13605157029

Xiling Shou, MD

Role: CONTACT

chmengx@hotmail.com

+8618966700335

Facility Contacts

Shuli M Zhao, MD

Role: primary

shuliz@126.com

+86-25-52271003

Ling F Lin, MD

Role: backup

linling@126.com

+86-25-52271--9

References

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: Rationale and design of an international, multicenter, randomized IVI-DIABETES trial. Am Heart J. 2025 May;283:81-88. doi: 10.1016/j.ahj.2025.01.017. Epub 2025 Feb 4.

Reference Type: DERIVED

PMID: 39914556 (View on PubMed)

Other Identifiers

Nanjing-2

Identifier Type: -

Identifier Source: org_study_id