By InvitationNot Applicable

The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR

South Korea94 participantsStarted 2025-02-19

Plain-language summary

The objective of this study is to evaluate the safety and effectiveness of Genoss® SCB by comparing in-segment late lumen loss (LLL) to the control group (SeQuent® Please NEO) at 6 months in patients with coronary stent-in-stent restenosis (ISR) with a reference vessel diameter of 2.0-4.0 mm.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. In asymptomatic patients: in-segment percent diameter stenosis (DS%) \> 70% compared to the reference vessel diameter of the target vessel\* (\*Target vessel: the vessel containing the target lesion with the minimum lumen diameter.)
✓. In patients with angina symptoms or evidence of ischemia on non-invasive functional testing: DS% \> 50%

Exclusion criteria

✕. Lesions in the left main coronary artery.
✕. Triple-vessel coronary artery disease.
✕. Other conditions requiring CABG as determined by the investigator.
✕. Total occlusion of the target lesion.
✕. Evidence of thrombus not treatable with aspiration.
✕. Severe vessel tortuosity or calcification preventing access to the target site, as determined by the investigator.
✕. Other conditions deemed unsuitable for investigational device application by the investigator.
✕. Need for atherectomy (rotational, orbital, or laser).

What they're measuring

In-segment late lumen loss after procedure

Timeframe: at 6 months after procedure

Trial details

NCT IDNCT07159087

SponsorGenoss Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More Coronary Arterial Disease (CAD) trials