An interventional study of Paclitaxel Coated PTCA Balloon Catheter in Coronary Artery Disease, sponsored by Genoss Co., Ltd.. Completed. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Genoss Co., Ltd. · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please)
In a randomized controlled trials to compare with the same-category medical device (Sequent® Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.
Drug release "stents" for PCI usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is different from the stent and the duration of follow up was set to 6 months.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 82 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Genoss Co., Ltd. is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Paclitaxel Coated PTCA Balloon Catheter
Device: Paclitaxel Coated PTCA Balloon Catheter
Paclitaxel Coated PTCA Balloon Catheter
Device: Paclitaxel Coated PTCA Balloon Catheter
Drug coated balloon
In-segment late lumen loss after percutaneous coronary intervention in patients with ISR
In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR
Time frame: Follow-up angiography at 6 months after procedure
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Genoss Co., Ltd.