Nordic IVUS Study: Prospective Clinical Observational Registry Study Including Consecutive Patients With Clinical Signs or Symptoms Due to In-stent Restenosis (ISR) or Definite (ARC Criteria) Stent Thrombosis (ST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- Tabulation and classification of IVUS outcomes
研究概览
简要总结
Prospective clinical observational registry study including consecutive patients with clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent thrombosis (ST).
Study hypothesis:
Initial Stent implantation quality (due to technique/problems) are possible major determinants of ST and ISR in real life practice.
Both early, late, and very late ST, and ISR are important factors for long term outcome after initial stent implantation.
Primary objective:
- To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation in real life practice by clinical, angiographic and IVUS evaluation.
Secondary objective:
- To describe the clinical manifestation [stable angina pectoris (AP), unstable AP, non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation MI] of the index event (inclusion).
- To describe the characteristics of patient, lesion and procedure of the initial percutaneous coronary intervention (PCI).
- To describe the antithrombotic pharmacological therapy preceding the index event.
- To describe clinical outcome (death, MI, revascularization, CCS angina class) following treatment of the index event during 12 month follow-up.
- To describe safety of the IVUS procedure (product or procedural related complications/ malfunctions).
详细描述
Investigational sites:
10-15 high volume Nordic PCI centres with experience in intravascular ultrasound (IVUS).
Patients:
- All consecutive patients admitted with an ischemic event due to ST (estimated number of patients >100) either with BMS or DES.
- All consecutive patients with symptoms or signs of ischemia due to in-stent restenosis with DES (target about 200 patients) and respective BMS patients up to maximum 100 patients.
Total number of patients 400. Control groups 1) Lesions treated during the initial PCI, other than the index lesion, will be used as control lesions for the stent with failure; ST or ISR (IVUS findings).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •All Consecutive consented patients with a suspected ST either with BMS or DES. (estimated number of patients >100), admitted to one of the participating hospitals:
- •Typical symptoms or evidence of myocardial ischemia (stable AP, UAP/NSTEMI, STEMI)
- •Clinical suspicion of ST is based on the ARC criteria (probable ST). ST will be verified by coronary angiography.
- •All consecutive patients with symptoms or signs of ischemia (angina pectoris, unstable angina, NSTEMI, STEMI, or documented myocardial ischemia) due to ISR with DES (target about 200 patients) and respective BMS patients up to maximum 100 patients.
排除标准
- •Informed consent cannot be obtained
结局指标
主要结局
Tabulation and classification of IVUS outcomes
时间窗: first day
次要结局
- IVUS procedure related events(1 week)
- Outcome of treatment during the 12 month follow-up: clinical status and major cardiac events(12 months follow-up)
- Clinical manifestation of the index event(12 months)
- Compliance to antithrombotic therapy(12 month follow-up)
- Tabulation and classification of angiographic outcomes(first day)