DRKS00024618招募中未知
A randomized controlled trial to compare the safety and efficacy of siroliMUs-eLuTIng biodegradable polymer ulTrA-thin stent (SUPRAFLEX TM Cruz) and everolimus-eLuting biodegradable polymer stent (SYNERGYTM) in treatmENT for three-vessel coronary artery disease: Multivessel TALENT - Multivessel TALENT
ational University Ireland Galway0 个研究点目标入组 1,550 人开始时间: 2021年2月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 1,550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Male or female patients’ =18 years.
- •2. At least 1 stenosis (angiographic, visually determined de novo lesions with =50% DS) in all 3 major epicardial territories (LAD and/or side branch, LCX and/or side branch, RCA and/or side branch) supplying viable myocardium without left main involvement*;
- •*patients with ostial LAD or ostial LCX - Medina 0,0,1 or Medina 0,1,0 – may be enrolled; Patients with hypoplastic RCA (or LCX) with absence of descending posterior and presence of a lesion in the LAD and LCX (or RCA) territories may be included in the trial as a 3VD equivalent.
- •3. The vessel should have a reference vessel diameter ranging from =2.25 mm to =4.50 mm (no limitation on the number of treated lesions, vessels, or lesion length).
- •4. Patients with chronic coronary syndrome 1 or stabilized acute coronary syndromes**;
- •**For patients showing elevated Troponin (e.g. nonSTEMI patients) at baseline (within 72h pre-PCI) an additional blood sample must be collected prior to randomisation to confirm that:
- •- hs-cTn or Troponin I or T levels are stable (i.e. the value should be within 20% range of the value found inthe first sample at baseline, or shown any decline.)
- •- or CK-MB and CK levels are within normal range
- •In summary, If hs-cTn or Troponin I or T levels are stable or have dropped,or CK-MB and CK levels are within normal range, and the ECG does not show STelevation, the patient may be included in the study.
- •In case where both enzymes are available, troponin criteria are hierarchically dominant.
- •5. All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II, provided that the SYNTAX Score II recommends equipoise risk (PCI or CABG) or PCI only;
- •6. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocolrequired evaluations;
排除标准
- •1. Under the age of 18.
- •2. Unable to give informed consent.
- •3. Patient is a woman who is pregnant or nursing (apregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice);
- •4. Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor.
- •5. Prior PCI or prior CABG;
- •6. Ongoing ST-elevation myocardial infarction (STEMI);
- •7. Cardiogenic shock is also an exclusion criteria
- •8. Concurrent medical condition with a life expectancy of less than 2 years; 9. Currently participating in another trial and not yet at its
- •primary endpoint;
- •10. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis
- •11. Previous intracranial haemorrhage
研究者
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