DiabetesIVI-DIABETESNCT06380868
IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus
A study testing Intravascular imaging-guided PCI and Angiography-guided PCI group in people with Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Intravascular imaging-guided PCI and Angiography-guided PCI group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,332 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2024to 20 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Shuli M Zhao, MD, +86-25-52271003, shuliz@126.com
Ling F Lin, MD, +86-25-52271--9, linling@126.com
About this study
Official title: Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
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.
Read the 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
- Being tested
- Intravascular imaging-guided PCI, Angiography-guided PCI group
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular imaging-guided PCIProcedure or surgery
Intravascular imaging including intravascular ultrasound or optical coherence tomography.
Angiography-guided PCI groupProcedure or surgery
Deployment of a drug-eluting stent under angiography.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Angiography-guided PCI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At one-year since interventions
Secondary outcomes (7)
Rate of target vessel failure without procedure-related MI
Procedural-related myocardial infarction (PMI) would be excluded from the calculation of TVF
Measured: At one-year since interventions
Rate of cardiac death
Any death without clear reasons
Measured: At one-year since interventions
Rate of all-cause death
Any death occurs within one-year follow-up
Measured: At one-year since interventions
Rate of procedure-related myocardial infarction (PMI)
48 hours after coronary intervention
Measured: Within 48 h since coronary intervention
Rate of spontaneous myocardial infarction (SMI)
MI happens between 48 h and one-year since coronary intervention
Measured: Within one-year follow-up
Rate of clinically-driven revascularization
Target vessel revascularization was defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, which included upstream and downstream branches and the target lesion itself.
Measured: At one-year since coronary artery intervention
Rate of stent thrombosis
Definite or probable stent thrombosis
Measured: At one-year since coronary artery intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start17 Jul 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,332 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Jing Kan, MD, Principal investigator, Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380868
- Sponsor's protocol ID
- Nanjing-2
- Acronym
- IVI-DIABETES
- Status last verified
- May 2026
- First submitted
- 25 Mar 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39914556
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
- ClinicalTrials.gov ID
- NCT06380868
- Acronym / sponsor ID
- IVI-DIABETES / Nanjing-2
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,332 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravascular imaging-guided PCI group | Experimental | Procedure: Intravascular imaging-guided PCIFor patients in this group, intravascular imaging will be encouraged to performed prior-to and post-coronary intervention using new generation drug-eluting stents |
| Angiography-guided PCI group | Active comparator | Procedure: Angiography-guided PCI groupFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Cardiogenic shock
- Previous coronary artery bypass graft (CABG)
- Left ventricular ejection fraction < 30%
- Requiring oral anticoagulation medications
- Any planned surgery within 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular imaging-guided PCIIntravascular imaging including intravascular ultrasound or optical coherence tomography. | Procedure or surgery | Intravascular imaging-guided PCI group |
| Angiography-guided PCI groupDeployment of a drug-eluting stent under angiography. | Procedure or surgery | Angiography-guided PCI group |
Primary outcome
Rate of target vessel failure (TVF)
Time frame: At one-year since interventions
TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization
7 secondary outcomes
Rate of target vessel failure without procedure-related MI
Time frame: At one-year since interventions
Rate of cardiac death
Time frame: At one-year since interventions
Rate of all-cause death
Time frame: At one-year since interventions
Rate of procedure-related myocardial infarction (PMI)
Time frame: Within 48 h since coronary intervention
Rate of spontaneous myocardial infarction (SMI)
Time frame: Within one-year follow-up
Rate of clinically-driven revascularization
Time frame: At one-year since coronary artery intervention
Rate of stent thrombosis
Time frame: At one-year since coronary artery intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 39914556Gao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Kan, MD principal investigator
Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular imaging-guided PCI and Angiography-guided PCI group in people with Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shao-Liang C Chen, MD (13605157029, chmengx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of target vessel failure (TVF) (time frame: At one-year since interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.