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

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy of Paclitax Drug Coated Balloon Catheter (Genoss® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study (GENISPIRE Registry)

Conditions
-----------------
In-stent Restenosis

Intervention / Treatment
-----------------
* Device: Genoss® DCB


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paclitaxel Coated Balloon<br>Patients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR) | Device: Genoss® DCB<br>* Paclitaxel coated balloon with a shellac plus vitamin E excipient<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Targeted lesion failure | A composite of cardiac death, target-vessel MI, or target lesion revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | A composite of all-cause death, MI, or revascularization | 12 months | 
| All-cause death | All-cause death and cardiac death | 12 months | 
| Any MI | Any MI and target vessel MI | 12 months | 
| Any revascularization | Any revascularization and ischemic driven target lesion revascularization | 12 months | 
| Major bleeding events, BARC 3, 5 | A composite rate of major bleeding events, BARC 3, 5 | 12 months | 
| Any Stroke | Ischemic or hemorrhagic stroke | 12 months | 
| Any stent thrombosis | Definite or probable stent thrombosis (acute, subacute, late) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In-stent Restenosis, Drug-coated balloon