跳至主要内容
临床试验/CTRI/2025/10/096100
CTRI/2025/10/096100招募中不适用

Long term Comparative Outcomes of Sirolimus versus Everolimus Eluting Coronary Stents A Single Centre Ambispective Study

Anil Neerukonda Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
1. Major Adverse Cardiac Events

研究概览

简要总结

Study Title: **DualDES:**Long-term Comparative Outcomes of Sirolimus- versus Everolimus-Eluting Coronary Stents A Single-Centre Ambispective Study

Study Design: A Real-World Evidence, Single-center, Observational, ambispective study.

Study Objective: This study aims to evaluate and compare the long-term safety, performance, and clinical outcomes of Sirolimus- versus Everolimus-eluting coronary stent systems in real-world patients with native coronary artery disease.

Rationale of the study: Drug-eluting stents (DES) have significantly improved the treatment of coronary artery disease (CAD) by reducing the incidence of restenosis, neointimal hyperplasia, and the need for repeat revascularization compared to bare-metal stents. Among the widely used DES, sirolimus- and everolimus-eluting stents utilize potent antiproliferative agents that inhibit smooth muscle cell proliferation and migration key contributors to restenosis. Both sirolimus and everolimus belong to the mTOR inhibitor class and are locally delivered at the site of the coronary lesion through polymer-coated stents. This targeted delivery maximizes efficacy at the lesion site while minimizing systemic drug exposure and related adverse effects. Although both agents share a similar mechanism of action, subtle differences in pharmacokinetics, stent design, polymer composition, and drug-release kinetics may influence their long-term clinical performance and safety profiles. This study aims to generate real-world, comparative evidence on the long-term safety, performance, and clinical outcomes associated with sirolimus- versus everolimus-eluting coronary stents in patients undergoing percutaneous coronary intervention

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients who have been treated with a Sirolimus- or Everolimus-Eluting Coronary Stent System and have completed a minimum of 1-year follow-up.
  • Participants who are willing to comply with study-related follow-up requirements.

排除标准

  • Patients who have not been treated with a Sirolimus- or Everolimus-Eluting Coronary Stent System or have not completed a minimum of 1-year follow-up.
  • Participants who are unwilling to comply with study-related follow-up requirements.

结局指标

主要结局

1. Major Adverse Cardiac Events

时间窗: 1. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days | 2. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days

2. Target Lesion Failure

时间窗: 1. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days | 2. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days

次要结局

  • 1. Target vessel failure(2. Quality of Life (QoL) questionnaire)

研究者

发起方
Anil Neerukonda Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Suresh Kumar Paidi

Anil Neerukonda Hospital

研究点 (1)

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