PCINCT07297641
Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR
An observational study of PCI and In-stent Restenosis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PCI, In-stent Restenosis, Intravascular Imaging Device
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Aug 2027
- Phase
- Observational
- 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
Study population: The first-time drug-eluting stent in-stent restenosis (DES-ISR) who underwent repeat percutaneous coronary intervention (re-PCI) under angiographic guidance or combined IVUS guidance.
Who may be able to join
- Patients with DES-ISR lesions; (2) Life expectancy of at least 1 year; (3) DES-ISR lesions occurring for the first time in native coronary arteries and suitable for re-PCI based on angiographic findings.
Who cannot join
- Bare-metal stent in-stent restenosis (BMS-ISR). (2) Non-DES-ISR lesions. (3) Incomplete clinical and angiographic data. (4) Poor quality of IVUS or angiographic images. (5) Recurrent DES-ISR. (6) Optical coherence tomography (OCT) guidance.
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
About this study
Official title: Intravascular Imaging-Guided Versus Angiography- Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.
Read the detailed description
Through early revascularization, percutaneous coronary intervention (PCI) and following pharmacotherapy have improved clinical prognosis among patients with coronary artery disease. However, the presence of stent failure events remained posing long-term risk of adverse cardiac events. Although the utilization of drug-eluting stents (DES), the incidence of in-stent restenosis (ISR) continued to occur at an incidence rate of 1-2% annually. Also, the prognosis of ISR was worse than that in denovo lesions considering its complex mechanisms(stent under-expansion, neointimal hyperplasia or neo-atherosclerosis).Compared with coronary angiography, intravascular imaging(OCT/IVUS) provides detailed anatomical information regarding reference vessel dimensions and lesion characteristics, including severity of diameter stenosis, lesion length, and morphology. Identifying the mechanism of stent failure is paramount because the causative factors will influence the selection of treatment strategy, ultimately impacting the prognosis of the revascularization. However, clinical evidence for the exact benefit of intravascular imaging-guidance for ISR lesions is limited.
Therefore, this study aimed to compare the efficacy and safety of intravascular imaging -guided PCI in patients with ISR.
- Conditions
- PCI, In-stent Restenosis, Intravascular Imaging Device
- Being tested
- percutaneous coronary intervention
- Keywords
- in-stent restenosis, Intravascular imaging device, percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
Percutaneous Coronary Intervention for ISR
| Study group | Role | What they receive |
|---|---|---|
| Intravascular imaging -guidance | Individuals underwent intravascular imaging -guided PCI for lesions diagnosed with ISR Receives: Procedure: percutaneous coronary intervention | |
| Angiography-guidance | Individuals underwent angiography-guided PCI for lesions diagnosed with ISR Receives: Procedure: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Major adverse cardiovascular events following PCI
Measured: 3-year
Secondary outcomes (2)
Stent expansion
defined as the final minimal luminal area (MLA) within the treatment segment divided by the average reference vessel area
Measured: Intraprocedural
MSA
minimal stent area
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Aug 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 PCIStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye-fei, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Fei Ye, Principal investigator, Nanjing First Hospital, Nanjing Medical University, 210006 Nanjing, Jiangsu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297641
- Sponsor's protocol ID
- KY20241223-KS-02
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy and ethical limitations, the data generated and analyzed in current study are not publicly available but could be obtained from principal investigator upon the approval of ethics committee
Publications
Wang YF, Xu T, Meng PN, You W, Xu Y, Kong XH, Wu XQ, Wu ZM, Zhao MY, Jia HB, Wang F, Ye F. Optical coherence tomography versus angiography to guide percutaneous coronary intervention in patients with in-stent restenosis: an observational study. Coron Artery Dis. 2025 Mar 1;36(2):108-116. doi: 10.1097/MCA.0000000000001458. Epub 2024 Dec 3.
PubMed 39620882
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Imaging-Guided Versus Angiography- Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
- ClinicalTrials.gov ID
- NCT07297641
- Acronym / sponsor ID
- KY20241223-KS-02
- Conditions
- PCI, In-stent Restenosis, Intravascular Imaging Device
- Keywords
- in-stent restenosis, Intravascular imaging device, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Dec 2025 (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.
This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.
Detailed description
Through early revascularization, percutaneous coronary intervention (PCI) and following pharmacotherapy have improved clinical prognosis among patients with coronary artery disease. However, the presence of stent failure events remained posing long-term risk of adverse cardiac events. Although the utilization of drug-eluting stents (DES), the incidence of in-stent restenosis (ISR) continued to occur at an incidence rate of 1-2% annually. Also, the prognosis of ISR was worse than that in denovo lesions considering its complex mechanisms(stent under-expansion, neointimal hyperplasia or neo-atherosclerosis).Compared with coronary angiography, intravascular imaging(OCT/IVUS) provides detailed anatomical information regarding reference vessel dimensions and lesion characteristics, including severity of diameter stenosis, lesion length, and morphology. Identifying the mechanism of stent failure is paramount because the causative factors will influence the selection of treatment strategy, ultimately impacting the prognosis of the revascularization. However, clinical evidence for the exact benefit of intravascular imaging-guidance for ISR lesions is limited.
Therefore, this study aimed to compare the efficacy and safety of intravascular imaging -guided PCI in patients with ISR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular imaging -guidance | – | Procedure: percutaneous coronary interventionIndividuals underwent intravascular imaging -guided PCI for lesions diagnosed with ISR |
| Angiography-guidance | – | Procedure: percutaneous coronary interventionIndividuals underwent angiography-guided PCI for lesions diagnosed with ISR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first-time drug-eluting stent in-stent restenosis (DES-ISR) who underwent repeat percutaneous coronary intervention (re-PCI) under angiographic guidance or combined IVUS guidance.
Key inclusion criteria (1 listed)
- Patients with DES-ISR lesions; (2) Life expectancy of at least 1 year; (3) DES-ISR lesions occurring for the first time in native coronary arteries and suitable for re-PCI based on angiographic findings.
Key exclusion criteria (1 listed)
- Bare-metal stent in-stent restenosis (BMS-ISR). (2) Non-DES-ISR lesions. (3) Incomplete clinical and angiographic data. (4) Poor quality of IVUS or angiographic images. (5) Recurrent DES-ISR. (6) Optical coherence tomography (OCT) guidance.
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 |
|---|---|---|
| percutaneous coronary interventionPercutaneous Coronary Intervention for ISR | Procedure or surgery | Angiography-guidance, Intravascular imaging -guidance |
Primary outcome
MACE
Time frame: 3-year
Major adverse cardiovascular events following PCI
2 secondary outcomes
Stent expansion
Time frame: Intraprocedural
MSA
Time frame: Intraprocedural
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 22 Dec 2025.
- Results publication: PubMed 39620882Wang YF, Xu T, Meng PN, You W, Xu Y, Kong XH, Wu XQ, Wu ZM, Zhao MY, Jia HB, Wang F, Ye F. Optical coherence tomography versus angiography to guide percutaneous coronary intervention in patients with in-stent restenosis: an observational study. Coron Artery Dis. 2025 Mar 1;36(2):108-116. doi: 10.1097/MCA.0000000000001458. Epub 2024 Dec 3.
- Individual participant dataSharing planned: No. Due to privacy and ethical limitations, the data generated and analyzed in current study are not publicly available but could be obtained from principal investigator upon the approval of ethics committee
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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.
Fei Ye principal investigator
Nanjing First Hospital, Nanjing Medical University, 210006 Nanjing, Jiangsu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCI and In-stent Restenosis, 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 1 inclusion and 1 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 22 Dec 2025. 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 Fei Ye, MD (18951670287 +86, doctor_ye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 3-year). 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 NCT07297641, 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 22 Dec 2025.