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Идёт набор NCT06104007

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

— Наблюдательное Coronary Artery Disease In-stent Restenosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Genoss® DCB.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease, In-stent Restenosis. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
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Обзор

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).

Подробное описание

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.

Вмешательства

  • Устройство Genoss® DCB
    This study includes patients with coronary in-stent restenosis (ISR) who have undergone percutaneous coronary intervention (PCI) according to standard treatment protocols using the Genoss® DCB and have agreed to participate in the clinical research. The decision on which drug-coated balloon (DCB) to use during PCI is entirely based on the patient's condition and the characteristics of the coronary lesions identified through angiography. Thus, it's not possible to determine in advance to use the

Первичные конечные точки

  • Target lesion failure [Срок оценки: 1 year]
Вторичные конечные точки (10)
  • Major adverse cardiac event [Срок оценки: 1 year]
  • All-cause death [Срок оценки: 1 year]
  • Cardiac death [Срок оценки: 1 year]
  • Myocardial infarction [Срок оценки: 1 year]
  • Target vessel myocardial infarction [Срок оценки: 1 year]
  • Revascularization [Срок оценки: 1 year]
  • Ischemic driven target lesion revascularization [Срок оценки: 1 year]
  • Major bleeding (BARC type 3, 5) [Срок оценки: 1 year]
  • Stroke [Срок оценки: 1 ye]
  • Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year) [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.
  • Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.

Критерии исключения

  • Women of childbearing age who plan to become pregnant during the study duration.
  • Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.
  • Patients for whom the expected remaining life span is less than one year.
  • Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.
  • Patients currently involved in a randomized medical device study.
  • Patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Bon-Kwon Koo — Seoul

Идентификаторы

NCT: NCT06104007 · 2304-037-1420

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗