Active — Not RecruitingNot Applicable

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

South Korea260 participantsStarted 2022-08-31

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Targeted lesion failure

Timeframe: 12 months

Trial details

NCT IDNCT05656118

SponsorYonsei University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More In-stent Restenosis trials