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NCT07159087
The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR
NA trial testing Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB) in Coronary Arterial Disease (CAD) in 94 participants. Enrolling by invitation.
31 July 2026
Quick facts
| Lead sponsor | Genoss Co., Ltd. |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 94 |
| Start date | 19 February 2025 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 January 2027 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB)
- Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
Conditions studied
- Coronary Arterial Disease (CAD) — all drugs for Coronary Arterial Disease (CAD) →
Sponsor
Genoss Co., Ltd.
Who can join
19 and older, any sex, with Coronary Arterial Disease (CAD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07159087
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Genoss Co., Ltd. trials
Trials by the same sponsor.
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- NCT07431437 — One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease · enrolling by invitation
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- NCT06168305 — Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07159087 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genoss Co., Ltd.
- Last refreshed: 8 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07159087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing