Intravascular imaging–guided versus angiography-guided repeat PCI for drug-eluting stent in-stent restenosis
Official title: Intravascular Imaging-Guided Versus Angiography- Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
Run by Nanjing First Hospital, Nanjing Medical University · NCT07297641 · Data updated 2026-11-12
This trial tests whether using intravascular imaging (primarily IVUS) to guide repeat PCI gives better clinical and angiographic results than angiography alone for people with drug-eluting stent in-stent restenosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | November 1, 2026 |
| Study ends | August 1, 2027 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT07297641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with first-time DES-ISR in native coronary arteries who are suitable for repeat PCI and have a life expectancy of at least one year are eligible.
✕Probably not a fit
Patients with bare-metal stent restenosis, non-DES lesions, recurrent DES-ISR, poor-quality imaging, or those undergoing OCT-guided procedures are not represented and may not benefit from these results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center observational comparison of patients with first-time DES-ISR who underwent repeat PCI guided either by intravascular imaging (primarily IVUS) or by angiography alone. Investigators collect clinical and angiographic outcomes to compare safety and efficacy between the two guidance strategies. Patients with poor image quality, recurrent DES-ISR, BMS-ISR, or OCT-guided procedures were excluded to keep the comparison focused. The analysis aims to identify whether imaging guidance changes treatment selection and leads to improved restenosis or adverse event rates.
Why it matters
Potential benefit: If imaging guidance proves beneficial, it could lead to fewer repeat restenosis events and improved outcomes after treating DES-ISR.
How similar studies have gone: Prior research shows intravascular imaging can improve stent expansion and outcomes in de novo PCI, but direct evidence specifically proving benefit for DES-ISR is limited and inconclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Nanjing First Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Fei Ye — Nanjing First Hospital, Nanjing Medical University, 210006 Nanjing, Jiangsu, China
- Study coordinator: Fei Ye, MD
- Email: doctor_ye@126.com
- Phone: 18951670287 +86
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.