Clinical trial NCT05656118: Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: In-stent Restenosis
Keywords: In-stent Restenosis
Drug-coated balloon
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 260
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR)

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.

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.

Primary outcomes:
measure: Targeted lesion failure
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 12 months
measure: All-cause death
timeFrame: 12 months
measure: Any MI
timeFrame: 12 months
measure: Any revascularization
timeFrame: 12 months
measure: Major bleeding events, BARC 3, 5
timeFrame: 12 months
measure: Any Stroke
timeFrame: 12 months
measure: Any stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital, Yonsei University
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University College Hospital
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Korea University ANAM Hospital
Study officials:
affiliation: Yongin Severance Hospital, Yonsei University
name: Deok-Kyu Cho, MD
role: PRINCIPAL_INVESTIGATOR
References: