Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)
- Conditions
- In-stent Restenosis
- Interventions
- Device: Genoss® DCB
- Registration Number
- NCT05656118
- Lead Sponsor
- Yonsei University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 260
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.
-
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Paclitaxel Coated Balloon Genoss® DCB Patients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR)
- Primary Outcome Measures
Name Time Method Targeted lesion failure 12 months A composite of cardiac death, target-vessel MI, or target lesion revascularization
- Secondary Outcome Measures
Name Time Method Major adverse cardiovascular events 12 months A composite of all-cause death, MI, or revascularization
Any revascularization 12 months Any revascularization and ischemic driven target lesion revascularization
Any MI 12 months Any MI and target vessel MI
Any Stroke 12 months Ischemic or hemorrhagic stroke
Any stent thrombosis 12 months Definite or probable stent thrombosis (acute, subacute, late)
All-cause death 12 months All-cause death and cardiac death
Major bleeding events, BARC 3, 5 12 months A composite rate of major bleeding events, BARC 3, 5
Trial Locations
- Locations (4)
Inje University Ilsan Paik Hospital
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of
Yongin Severance Hospital, Yonsei University
🇰🇷Yongin-si, Gyeonggi-do, Korea, Republic of
Kyungpook National University College Hospital
🇰🇷Daegu, Gyeongsangnam-do, Korea, Republic of
Korea University ANAM Hospital
🇰🇷Seoul, Korea, Republic of