NCT06380868 IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
| NCT ID | NCT06380868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,332 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,332 participants in total. It began in 2024-07-17 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.)
Contact & Investigator
Jing Kan, MD
PRINCIPAL INVESTIGATOR
Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China
Frequently Asked Questions
Who can join the NCT06380868 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06380868 currently recruiting?
Yes, NCT06380868 is actively recruiting participants. Contact the research team at chmengx@126.com for enrollment information.
Where is the NCT06380868 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06380868 clinical trial?
NCT06380868 is sponsored by Nanjing First Hospital, Nanjing Medical University. The principal investigator is Jing Kan, MD at Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China. The trial plans to enroll 1,332 participants.
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