Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Rate of occurrence of combined endpoint at 335 days: net averse clinical event (death from any cause, infarction and non-fatal stroke) + (BARC major bleeds >3)).
研究概览
简要总结
High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. European guidelines therefore authorize one-month DAPT in HBR patients presenting even an acute coronary syndrome.
The HT Supreme Drug Coated Coronary Stent System (HT Supreme DES) is designed to promote reendothelialization as quickly as possible. That's why the stent is called "HT" Supreme, with "HT" standing for "Healing Targeted", enabling a DAPT of just 1 month in all-comers HBR patients.
Thanks to these features, the investigators aim to demonstrate ischemic and hemorrhagic complication rates lower than those found in the literature with other stent.
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
- 否
入选标准
- •Patient aged ≥ 18 years
- •Male or female patient requiring a coronary angioplasty procedure according to European recommendations,
- •Patients undergoing revascularization with HT-supreme stents
- •Patient at high risk of bleeding according to ARC HBR definition (9).
- •Patient affiliated to or benefiting from a social security scheme
- •Patient who does not object to research
排除标准
- •Estimated lifespan <1 year,
- •Allergy and any other contraindication to aspirin and/or clopidogrel listed in the summary of product characteristics,
- •Allergy to iodinated contrast media
- •Adults under legal protection (guardianship, curatorship or safeguard of justice).
- •Persons deprived of their liberty by judicial or administrative decision,
- •Patient in a period of relative exclusion from another research protocol,
结局指标
主要结局
Rate of occurrence of combined endpoint at 335 days: net averse clinical event (death from any cause, infarction and non-fatal stroke) + (BARC major bleeds >3)).
时间窗: At 335 days
Validate the non-inferiority of the frequency of occurrence at 335 days after a short DAPT (1 month) of a combined endpoint, net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds \>3) occurring in patients implanted with an HT supreme™ coronary stent in HBR patients to the ultimaster stent (Terumo)
次要结局
- Comparison of primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) frequency in patients with HBR and high ischemic risk.(At 335 days and one year)
- Evaluate the one-year frequency of death from any cause(At 335 days and one year)
- Evaluate the one-year frequency of cardiovascular deaths(At 335 days and one year)
- Evaluate the one-year incidence of myocardial infarction(At 335 days and one year)
- Evaluate the one-year incidence of ischemic stroke(At 335 days and one year)
- Evaluate the one-year incidence of defined stent thrombosis(One year)
- Evaluate the frequency of other cardiovascular adverse events(at 335 days and One year)
- Evaluate the one-year frequency of ischemia-driven revascularizations(One year)
- Assess the one-year frequency of minor and major bleeding according to Bleeding Academic Research Consortium (BARC)(One year)
- Evaluate the rate of serious adverse events related to the device and/or investigation procedure.(At 335 and One year)