Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)
NCT ID: NCT05656118
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
260 participants
OBSERVATIONAL
2022-08-31
2028-12-31
Brief Summary
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The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Paclitaxel Coated Balloon
Patients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR)
Genoss® DCB
Paclitaxel coated balloon with a shellac plus vitamin E excipient
Interventions
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Genoss® DCB
Paclitaxel coated balloon with a shellac plus vitamin E excipient
Eligibility Criteria
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Inclusion Criteria
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
* 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.
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Deok-Kyu Cho
Professor, Department of Cardiology, Yongin Severance Hospital, Yonsei University College of Medicine
Principal Investigators
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Deok-Kyu Cho, MD
Role: PRINCIPAL_INVESTIGATOR
Yongin Severance Hospital, Yonsei University
Locations
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Kosin University Gospel Hospital
Busan, Busan, South Korea
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Yongin Severance Hospital, Yonsei University
Yongin-si, Gyeonggi-do, South Korea
Kyungpook National University College Hospital
Daegu, Gyeongsangnam-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Korea University ANAM Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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9-2022-0063
Identifier Type: -
Identifier Source: org_study_id
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