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

NCT05656118 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

  • In-stent Restenosis

Interventions

DEVICE

Genoss® DCB

Paclitaxel coated balloon with a shellac plus vitamin E excipient

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Deok-Kyu Cho, MD · Yongin Severance Hospital, Yonsei University

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656118 on ClinicalTrials.gov