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临床试验/NCT07378163
NCT07378163招募中不适用

Study on the Preferences for Percutaneous Coronary Intervention Implantation Devices Among Healthcare Providers and Patients With Coronary Artery Disease

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Maximum acceptable risk in the trade-off of death

研究概览

简要总结

The contemporary percutaneous treatment of coronary artery disease typically involves initial lesion preparation with balloon angioplasty, followed by the deployment of a drug-eluting stent (DES) to provide an immediate scaffold and reduce the long-term risk of restenosis. However, stent implantation continues to present notable challenges, primarily due to the metallic scaffold left behind. Compared to DES, drug-coated balloons (DCB) provide a direct release of antiproliferative drugs into the vessel wall, preventing coronary restenosis after angioplasty and limiting the risk of stent-related events. DCBs are an established treatment option for in-stent restenosis and small vessels. However, the REC-CAGEFREE I trial demonstrated that a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in patients with de novo, non-complex coronary artery disease (CAD), irrespective of vessel diameter.

Previous studies have mainly focused on the efficacy of PCI strategies in reducing adverse event rates, while less attention has been paid to patients' willingness regarding stent implantation. The AHA conducted a systematic review on depression and poor prognosis among patients with acute coronary syndrome (ACS), concluding that health organizations should consider depression as an official risk factor for poor prognosis after ACS. A prior study of patients with coronary artery disease after stent implantation found that their anxiety stemmed primarily from concerns about the stent's long-term effects and its impact on their social interaction. However, data regarding patients' preferences on the selection of DES or DCB is scarce, and whether the psychological impact would differ between DES- or DCB-treated patients is still unknown. This study aimed to investigate the preferences of patients, as well as medical staff, for DES or DCB-based PCI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention;
  • Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire.
  • Healthcare providers who treat patients with coronary artery disease.

排除标准

  • Aged < 18 years;
  • Inability to understand the questionnaire or presence of cognitive impairment.

研究组 & 干预措施

Subjects

Medical staff and patients with CAD

干预措施: Questionnaire (Other)

结局指标

主要结局

Maximum acceptable risk in the trade-off of death

时间窗: Before discharge

To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.

Maximum acceptable risk in the trade-off of stroke

时间窗: Before discharge

To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.

Maximum acceptable risk in the trade-off of myocardial infarction

时间窗: Before discharge

To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.

Maximum acceptable risk in the trade-off of cardiopulmonary resuscitation

时间窗: Before discharge

To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.

Maximum acceptable risk in the trade-off of revascularization

时间窗: Before discharge

To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.

Maximum acceptable risk in the trade-off of rehospitalization

时间窗: Before discharge

To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Tao, MD, PhD

Professor in Cardiology, Director of the Department of Cardiology

Xijing Hospital

研究点 (1)

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