Actively Recruiting
IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-03-14
1332
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
Nanjing First Hospital, Nanjing Medical University
Lead Sponsor
S
Shanxi Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Confirmed diabetes mellitus
- Indication for PCI using a drug-eluting stent with invasive or quantitative fractional flow reserve (QFR or FFR) less than 0.80
- Diagnosis of silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction
You will not qualify if you...
- Cardiogenic shock
- Previous coronary artery bypass graft (CABG)
- Left ventricular ejection fraction less than 30%
- Requirement for oral anticoagulation medications
- Any planned surgery within 12 months
- Severe chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m2
- Platelet count less than 100,000 mm3
- Contraindication to study medications or metal
- Women of childbearing potential
- Life expectancy less than 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)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
S
Shao-Liang C Chen, MD
CONTACT
X
Xiling Shou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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