Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Location status: Recruiting
NCT Number: NCT07297641
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Nanjing, Jiangsu, 210006, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Percutaneous Coronary Intervention for ISR
Time frame: 3-year
Major adverse cardiovascular events following PCI
Time frame: Intraprocedural
defined as the final minimal luminal area (MLA) within the treatment segment divided by the average reference vessel area
Time frame: Intraprocedural
minimal stent area
Contact information is provided by the study sponsor or research team.
Fei Ye, MD
CONTACT
18951670287 +86
Yi-fei Wang, MD
CONTACT
18852577798 +86
Nanjing First Hospital, Nanjing Medical University
Other
Intravascular Imaging-Guided Versus Angiography- Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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