IVUS vs Angiography Guidance for Diabetes Patients
IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
Recruiting
N/AInterventional Study
Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
1,332 (estimated)
Sponsor
Nanjing First Hospital, Nanjing Medical University · Other
Who this trial is looking for
This trial is looking for patients with diabetes who need a procedure to open blocked arteries. Participating involves receiving either an ultrasound or standard imaging to guide the procedure.
Are You a Good Fit for This Trial?
Rules you outSevere kidney disease
You may be able to join if
I am between 18 and 80 years old
I have been diagnosed with diabetes
I need a procedure called PCI with a drug-eluting stent
I have silent angina, stable angina, unstable angina, or a heart issue called Non-ST-elevation myocardial infarction
You may not be able to join if
I am in cardiogenic shock
I have had heart surgery called CABG
My heart's pumping ability is low (ejection fraction < 30%)
I am taking blood thinners
I have severe kidney disease (eGFR < 20 ml/min/1.73m2)
My platelet count is low (< 100,000 mm3)
I cannot take the study medications or metal used in the study
I expect to live less than a year
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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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, …
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.)
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