Optical coherence tomography versus angiography to guide percutaneous coronary intervention in patients with in-stent restenosis: an observational study.
Yi-Fei Wang, Tian Xu, Pei-Na Meng...
https://pubmed.ncbi.nlm.nih.gov/39620882Actively Recruiting
Age: 18Years - 80Years
All Genders
ID07297641
Intravascular Imaging-Guided Versus Angiography-Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-12-22
1500
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the clinical and angiographic results in patients with drug-eluting stent in-stent restenosis (DES-ISR) who undergo repeat percutaneous coronary intervention (PCI) using either intravascular imaging or angiographic guidance. DES-ISR is a condition where a previously placed drug-eluting stent narrows again, leading to complex mechanisms that can affect long-term heart health. Intravascular imaging techniques like OCT or IVUS provide detailed information about the artery and lesion, which may influence treatment choices and outcomes. Participants receive repeat PCI using one of two approaches: intravascular imaging-guided PCI or angiography-guided PCI for lesions diagnosed with ISR. The study compares these two guidance methods to evaluate their efficacy and safety in treating DES-ISR. Treatment selection is based on detailed vessel and lesion characteristics obtained through these imaging methods. During the study, participants will be monitored for major adverse cardiac events (MACE) over three years, which is the primary outcome. Additional measurements taken during the procedure include stent expansion and minimal stent area (MSA). The study involves follow-up to assess clinical outcomes and angiographic data quality, ensuring safety and effectiveness of the imaging guidance methods in PCI for DES-ISR patients.
CONDITIONS
Brief Title
Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with drug-eluting stent in-stent restenosis (DES-ISR) lesions
- Life expectancy of at least 1 year
- DES-ISR lesions occurring for the first time in native coronary arteries and suitable for repeat PCI based on angiographic findings
- Adults aged 18 to 80 years
You will not qualify if you...
- Bare-metal stent in-stent restenosis (BMS-ISR)
- Non-DES-ISR lesions
- Incomplete clinical and angiographic data
- Poor quality of intravascular ultrasound (IVUS) or angiographic images
- Recurrent DES-ISR
- Use of optical coherence tomography (OCT) guidance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Percutaneous Coronary Intervention
Duration - Single procedure with intraprocedural assessments
Participants undergo percutaneous coronary intervention (PCI) guided either by intravascular imaging or angiography to treat drug-eluting stent in-stent restenosis lesions.
1 procedure visit (in-person)
Long-term Monitoring
Duration - 3 years
Participants are monitored for major adverse cardiac events and stent performance over a period of 3 years following the intervention.
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Loading map...
Research Team
F
Fei Ye, MD
Y
Yi-fei Wang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here