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

Recruiting
19 years of age
Both
Phase N/A

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Overview

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.

Description

260 subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR) will be recruited and followed up to 12 months.

All enrolled patients treated with Genoss DCB in patients with coronary in-stent restenosis (ISR) will be included in the analysis unless there is a valid reason or rationale for it, and the final statistical analysis will follow the intention-to-treat (ITT) principle as assigned. Standard descriptive statistics will be used for patient baseline characteristics, lesions, procedures, and clinical event outcomes. Categorical variables will be presented as percentages and numbers and compared using chi-square or Fisher's exact test. Continuous variables will appear as mean, standard deviation or median, and interquartile range, and will be compared with Student's T-test or Wilcoxon rank sum test, and the normal value of the standard variable distribution will be predicted through histogram, skewness, kurtosis, and Kolmogorov Smirnov one sample test.

Eligibility

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.

Study details

In-stent Restenosis

NCT05656118

Yonsei University

21 March 2024

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