NL-OMON51767招募中不适用
COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events - COMBINE-INTERVENE trial
Diagram B.V.0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients undergoing PCI, aged 30-80 years with any clinical presentation
- •2. Angiographic criteria: presence of >= 2 de novo target lesions* located in 2
- •different native coronary arteries feasible for treatment with PCI (operator /
- •Heart team decision)
- •Angiographic criteria target lesion* (all criteria I-IV should be applicable):
- •I. diameter stenosis >= 50% on visual estimation
- •II. de novo lesion located in native (non-grafted) vessel
- •III. lesion reference diameter of >= 2.0 mm
- •IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with
- •exclusion of culprit lesions)
- •*Target lesions are either culprit myocardial infarction lesions or lesions
- •where FFR will be performed. Patients are eligible if they have >= 2 target
- •lesions or one culprit and >= 1 target lesion.
排除标准
- •1. Patients with multivessel disease requiring coronary artery bypass grafting
- •(CABG) treatment (operator / local heart team decision)
- •2. Lesion located in a grafted segment or in a vein graft
- •3. In-stent restenosis lesions
- •4. Left main trifurcation
- •5. Left main lesion stand-alone (without other lesions)
- •6. Patients with severe tortuous lesions (where FFR and OCT is judged
- •impossible or dangerous)
- •7. Chronic total occlusion
- •8. Spontaneous coronary dissection
- •9. Patients with severe valvular heart disease likely to require cardiac
- •surgery within the next 2 years
- •10. Patients with left ventricle (LV) function less than 30%
- •11. Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2;
- •Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
- •12. Life expectancy less than 3 years
研究者
相似试验
尚未招募
不适用
Evaluation of the present pressure criteria for a patient to undergo coronary stentingCTRI/2022/08/044996Diagram BV
招募中
不适用
Investigator Initiated, Multi center, Multi-Country Study to Assess Clogged Heart Vessels to Minimize Cardiovascular EventsCTRI/2022/03/041188Erasmus Academical Hospital Universit Libre de Bruxelles
进行中（未招募）
不适用
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular EventsMultivessel Coronary Artery DiseaseIschemiaVulnerable PlaqueCoronary Artery DiseaseNCT05333068Diagram B.V.1,223
招募中
不适用
Vascular Territory of Acute Ischemic Lesions ; Distribution and its Association with Stroke SubtypeDiseases of the nervous systemKCT0000247Seoul National University Bundang Hospital2,700
进行中（未招募）
1 期
Acute Myocardial infarction Upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next three Days (NSTEMI), and randomized to Subcutaneous Evolocumab or Normal strategies to reach guidelines LDL objectives in the real-world- The AMUNDSEN-real studyEUCTR2021-000573-80-FRAPHP DRCI