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

NCT06380868 | Recruiting DMC

• 1 other identifier: Nanjing-2
• Study Type: interventional
• Target: 1,332
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of target vessel failure without procedure-related MI

  At one-year since interventions

• Rate of cardiac death

  At one-year since interventions

• Rate of all-cause death

  At one-year since interventions

• Rate of procedure-related myocardial infarction (PMI)

  Within 48 h since coronary intervention

• Rate of spontaneous myocardial infarction (SMI)

  Within one-year follow-up

Study Arms (2)

Intravascular imaging-guided PCI group

EXPERIMENTAL

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

Procedure: Intravascular imaging-guided PCI

Angiography-guided PCI group

ACTIVE COMPARATOR

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.

Procedure: Angiography-guided PCI group

Interventions

Intravascular imaging-guided PCI PROCEDURE

Intravascular imaging including intravascular ultrasound or optical coherence tomography.

Intravascular imaging-guided PCI group

Angiography-guided PCI group PROCEDURE

Deployment of a drug-eluting stent under angiography.

Angiography-guided PCI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead
• Shanxi Provincial People's Hospital: collaborator

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39914556 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jing Kan, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao-Liang C Chen, MD

CONTACT

13605157029; chmengx@126.com

Xiling Shou, MD

CONTACT

+8618966700335; chmengx@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed in the catheter laboratory by an invasive nurse. Staff in the catheter laboratory will be not blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 24, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 20, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)