Набор скоро начнётся NCT07009938

DCB for CAD With Type 2 Diabetes

Без фазы С лечением Coronary Artery Disease Diabete Type 2

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: Drug-Coated Balloon (DCB), Drug-Eluting Stent (DES) implantation.
Кому может быть актуально: Состояния в реестре: Coronary Artery Disease, Diabete Type 2. Базовые параметры: от 18 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Long-Term Efficacy and Safety of Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease and Type 2 Diabetes: A Multicenter, Prospective, Randomized Controlled Trial

Обзор

Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Drug-coated balloons (DCBs) offer a "leave nothing behind" strategy by delivering anti-proliferative drugs without permanent implants, potentially reducing restenosis and adverse events. Although DCBs have shown promise in selected lesion types, evidence in T2DM patients is limited, particularly from prospective, randomized trials. This study aims to evaluate the efficacy and safety of DCB angioplasty compared to conventional strategies in patients with CAD and T2DM, focusing on angiographic outcomes, symptom relief, and major adverse cardiovascular events.

Подробное описание

Coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often coexist, and the long-term hyperglycemic state and metabolic disorders in diabetic patients contribute to endothelial dysfunction and accelerated atherosclerosis. As a result, coronary lesions in T2DM patients tend to be more diffuse and complex, posing greater challenges to percutaneous coronary intervention (PCI). Although drug-eluting stents (DES) have significantly improved clinical outcomes, diabetic patients remain at higher risk for in-stent restenosis (ISR) and target lesion revascularization (TLR), negatively impacting long-term prognosis.

Drug-coated balloons (DCBs), a novel PCI technique, allow for rapid and effective delivery of anti-proliferative agents (e.g. paclitaxel or sirolimus) to the vessel wall without leaving behind a permanent implant. This "leave nothing behind" approach reduces the risk of chronic inflammation and stent-related complications. DCBs have shown promising results in non-diabetic populations, particularly in small vessel disease and bifurcation lesions. However, evidence supporting their use in T2DM patients remains limited, especially from prospective, randomized controlled trials. As such, whether DCBs can serve as a viable alternative to DES in this high-risk group remains an open question.

This study aims to evaluate the efficacy and safety of DCB angioplasty in patients with CAD and T2DM through a prospective, randomized controlled design. The study will focus on restenosis rates, improvement in angina symptoms, incidence of major adverse cardiovascular events (MACE), and patient-reported quality of life outcomes, providing a more individualized and evidence-based treatment approach for this challenging patient population.

Вмешательства

Устройство Drug-Coated Balloon (DCB)
Following lesion preparation (usually with a standard balloon), a drug-coated balloon is advanced to the target lesion. The balloon is inflated and maintained to allow effective drug transfer to the vessel wall.
Устройство Drug-Eluting Stent (DES) implantation
After coronary angiography identifies the target lesion, a DES is selected based on the vessel size. Post-deployment angiography is performed to confirm the result and check for complications.

Первичные конечные точки

Target Lesion Diameter Stenosis Rate [Срок оценки: At 12 months after intervention]

Вторичные конечные точки (4)

Major Adverse Cardiovascular Events (MACE) [Срок оценки: At 12 months after intervention]
Angina Symptom Improvement [Срок оценки: At baseline, 1, 3, 6 and 12 months after intervention]
Changes in glycemic indices including glycated hemoglobin (HbA1c) [Срок оценки: At 3, 6 and 12 months after intervention]
Glycemic indices [Срок оценки: At 3, 6 and 12 months after intervention]

Критерии участия

Критерии включения

Age ≥18 years
Diagnosed CAD with ≥70% stenosis in ≥1 coronary artery confirmed by coronary angiography
Diagnosed type 2 diabetes (per WHO criteria)
Target lesion suitable for DCB (diameter 2.0-4.0 mm, length ≤40 mm)
Informed consent provided