NCT07297641

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
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PCI
• In-stent Restenosis
• Intravascular Imaging Device

Interventions

Type	Name	Description
PROCEDURE	percutaneous coronary intervention	Percutaneous Coronary Intervention for ISR

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-11-01
• Completion: 2027-08-01
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: China