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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: In-stent Restenosis
• Intervention / Treatment: Device: Genoss® DCB

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.

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 24289
      • Kangwon National University Hospital
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
      • Inje University Ilsan Paik Hospital
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10444
      • National Health Insurance Service Ilsan Hospital
    • Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
      • Yongin Severance Hospital, Yonsei University
  • Gyeongsangnam-do
    • Daegu, Gyeongsangnam-do, Korea, Republic of, 136-705
      • Kyungpook National University College Hospital
    • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paclitaxel Coated Balloon; Patients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR)	Device: Genoss® DCB; Paclitaxel coated balloon with a shellac plus vitamin E excipient

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Deok-Kyu Cho, MD, Yongin Severance Hospital, Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: In-stent Restenosis; Drug-coated balloon
• Other Study ID Numbers: 9-2022-0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data set is available from the the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No