Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)

Conditions: In-stent Restenosis

Sex: All

Ages: 19 Years – N/A

Enrollment: 260

Sponsor: Yonsei University

Location: Korea, Republic of

Summary

The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.

Eligibility Criteria

Inclusion Criteria:① Age ≥18 years old.② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.Exclusion Criteria:A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months.Patients with life expectancy less than 1 year.Patients with cardiogenic shock and are predicted to have a low survival rate based on medical judgment.Patients participating in a medical device randomized controlled trials. ⑥ Patients who, in the judgment of the investigator, are not suitable for this clinical study or may increase the risks associated with participation in the study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05656118). StuddyBuddy aggregates publicly available trial information.