Health TrialsbyHealthPanel

Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study

ConditionsCoronary Artery DiseaseIn-stent Restenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

The SFRGENISTA study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with coronary in-stent restenosis (ISR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.

Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.

Disqualifiers

Women of childbearing age who plan to become pregnant during the study duration.

Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.

Patients for whom the expected remaining life span is less than one year.

Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.

Trial population

Patients with coronary in-stent restenosis who underwent percutaneous coronary intervention using the Genoss® DCB.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Genoss® DCB

    Device

    This study includes patients with coronary in-stent restenosis (ISR) who have undergone percutaneous coronary intervention (PCI) according to standard treatment protocols using the Genoss® DCB and have agreed to participate in the clinical research. The decision on which drug-coated balloon (DCB) to use during PCI is entirely based on the patient's condition and the characteristics of the coronary lesions identified through angiography. Thus, it's not possible to determine in advance to use the Genoss® DCB before the procedure, nor can the number of drug-coated balloon catheters to be used during the procedure be known or decided upon beforehand.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Genoss® DCB1 intervention

Trial outcomes

Primary outcomes

1

Target lesion failure

A composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization

Time frame
1 year

Secondary outcomes

1

Major adverse cardiac event

A composite of cardiac death, myocardial infarction, and revascularization

Time frame
1 year
2

All-cause death

All-cause death

Time frame
1 year
3

Cardiac death

Cardiac death

Time frame
1 year
4

Myocardial infarction

Myocardial infarction

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now