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 — SFRGENISTA

Coronary Artery Disease Clinical Trial

Official title:
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

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

Drug-coated balloon (DCB) treatment is a therapeutic strategy to overcome in-stent restenosis (ISR) that occurs after drug-eluting stent (DES) implantation. The 2018 European guidelines on myocardial revascularization recommend DCB treatment in patients with bare-metal stent (BMS) or DES ISR lesions. The Sequent Please World Wide Registry has shown that DCB therapy is safe and exhibits a low target lesion revascularization (TLR) rate in a large population. The Genoss® DCB is coated with 3µg/mm² of paclitaxel along with shellac, a hydrophilic excipient for rapid release and diffusion into the tissue. Additionally, it incorporates vitamin E, an antioxidant known to directly prevent the accumulation of smooth muscle cells associated with neointimal hyperplasia that arises from the vessel wall being damaged by the balloon catheter. The catheter was designed to enhance trackability and pushability, minimize vascular damage with the application of a hydrophilic coating to the distal part, and use a soft yet durable end-tip for easier access to the target lesion. In a clinical trial comparing Genoss® DCB to the Sequent® Please (B-BRAUN) DCB, the in-segment late lumen loss at six months after DCB was comparable, and the rates of adverse clinical events were similar. Given this background, this study intends to investigate the long-term efficacy and safety of the Genoss® DCB in patients with coronary ISR. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06104007
Study type	Observational
Source	Seoul National University Hospital
Contact	Bon-Kwon Koo, MD, PhD
Phone	+82-2-2072-2062
Email	bkkoo@snu.ac.kr
Status	Recruiting
Phase
Start date	August 17, 2023
Completion date	December 31, 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.