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

In-stent Restenosis Clinical Trial

— GENISPIRE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656118
• Other study ID #: 9-2022-0063
• Status: Recruiting
• Start date: August 31, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Yongcheol Kim, MD
• Phone: +82-031-5189-8967
• Email: yongcheol[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

? Age =18 years old.

? Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.

? 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. ? 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. ? 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.

Related Conditions & MeSH terms

• In-stent Restenosis

Intervention

Device:
• Genoss® DCB
Paclitaxel coated balloon with a shellac plus vitamin E excipient

Locations

Country	Name	City	State
Korea, Republic of	Yongcheol Kim	Yongin	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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