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

Intravascular Imaging-Guided Versus Angiography- Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07297641
Enrollment
1500
Registered
2025-12-22
Start date
2026-01-01
Completion date
2027-08-01
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In-stent Restenosis, Intravascular Imaging Device, PCI

Keywords

in-stent restenosis, Intravascular imaging device, percutaneous coronary intervention

Brief 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.

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.

Interventions

PROCEDUREpercutaneous coronary intervention

Percutaneous Coronary Intervention for ISR

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MACE3-yearMajor adverse cardiovascular events following PCI

Secondary

MeasureTime frameDescription
Stent expansionIntraproceduraldefined as the final minimal luminal area (MLA) within the treatment segment divided by the average reference vessel area
MSAIntraproceduralminimal stent area

Countries

China

Contacts

Primary ContactFei Ye, MD
doctor_ye@126.com18951670287 +86
Backup ContactYi-fei Wang, MD
happywangyf2018@163.com18852577798 +86

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026