Last reviewed · How we verify
NCT06104007: SFRGENISTA
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
trial testing Genoss® DCB in Coronary Artery Disease in 1,000 participants. Currently enrolling.
30 June 2028
Quick facts
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 17 August 2023 |
| Primary completion | 30 June 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Genoss® DCB
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- In-stent Restenosis — all drugs for In-stent Restenosis →
Sponsor
Seoul National University Hospital
Who can join
19 and older, any sex, with Coronary Artery Disease or In-stent Restenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06104007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Genoss® DCB
Trials testing the same drug.
- NCT05656118 — Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR) · active not recruiting
- NCT05134545 — Compare the Effectiveness and Safety of Genoss® DCB and IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease · NA · completed
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other Seoul National University Hospital trials
Trials by the same sponsor.
- NCT07262944 — EOI Block in Otoplasty With Rib Cartilage Graft · NA · recruiting
- NCT07464210 — Nemtabrutinib, Bortezomib, and Rituximab for WM · Phase 2 · not yet recruiting
- NCT07550803 — Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery · NA · not yet recruiting
- NCT07522138 — Home-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study · NA · not yet recruiting
- NCT07476651 — Scout Dose of Resin Microspheres · NA · recruiting
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 NCT06104007 (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 Seoul National University Hospital
- Last refreshed: 27 October 2023
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/NCT06104007.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing