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Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR

NCT ID: NCT07297641

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-08-01

Brief Summary

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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

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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

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PCI In-stent Restenosis Intravascular Imaging Device

Keywords

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in-stent restenosis Intravascular imaging device percutaneous coronary intervention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intravascular imaging -guidance

Individuals underwent intravascular imaging -guided PCI for lesions diagnosed with ISR

percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous Coronary Intervention for ISR

Angiography-guidance

Individuals underwent angiography-guided PCI for lesions diagnosed with ISR

percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous Coronary Intervention for ISR

Interventions

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percutaneous coronary intervention

Percutaneous Coronary Intervention for ISR

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

(1) 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.

Exclusion Criteria

(1) 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ye-fei

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fei Ye

Role: PRINCIPAL_INVESTIGATOR

Nanjing First Hospital, Nanjing Medical University, 210006 Nanjing, Jiangsu, China

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fei Ye, MD

Role: CONTACT

Phone: 18951670287 +86

Email: [email protected]

Yi-fei Wang, MD

Role: CONTACT

Phone: 18852577798 +86

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 39620882 (View on PubMed)

Other Identifiers

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KY20241223-KS-02

Identifier Type: -

Identifier Source: org_study_id