Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 10
- 主要终点
- minimal flow area assessed by OFDI
研究概览
简要总结
The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.
详细描述
Primary percutaneous coronary intervention has been well established as the treatment of choice for the majority of patients presenting with acute ST elevation myocardial infarction (STEMI). However primary PCI alone is unable to remove intracoronary thrombus and this often results in distal embolisation, no reflow which in turn leads to impaired myocardial perfusion. This can result in left ventricular dysfunction and subsequently increased mortality.
The use of thrombectomy devices during percutaneous coronary intervention in the setting of acute ST elevation myocardial infarction has been recently shown to improve epicardial, myocardial perfusion, angiographical TIMI flow, blush score, or result in less embolisation. Moreover thrombus aspiration or rheolysis has been shown to decrease cardiac death and repeat myocardial infarction.
It is estimated that late stent malapposition is more common after stenting in the course of primary PCI as compared with elective PCI, and may predispose to stent thrombosis. Late malapposition may be related to underdeployment of stents at the time of primary PCI, and this may be due in part to thrombus behind the stent, which subsequently resolves and leads to stent malapposition. Removal of thrombus before stenting potentially could lead to better stent expansion and less late malapposition.
On the other hand, the impact of thrombus on acute and chronic luminal dimension is still unclear in a setting of primary PCI. After stenting, such thrombus either I) protrude into the lumen through the mesh of metallic stent struts or II) is crushed between the vessel wall and stent. Theoretically, the protruded thrombus can hinder the intra-luminal flow immediately after stenting, while the resorption of crushed thrombus against vessel wall might result at long term in stent malaposition.
Due to the limited ability of the conventional angiography and the intravascular ultrasound (IVUS) to detect thrombus, these aspects have not been investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 is at least 18 years of age.
- •Patients with a ST-elevation Myocardial Infarction documented in an ambulance or in a Cathlab with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min and having an angiographical visible stenosis (>30%) or TIMI≤ II in de-novo, native, previously unstented vessel.
- •The single vessel coronary artery disease.
- •Signed Informed Consent.
- •The patient understands and accepts clinical follow-up and OFDI controls.
- •Patients residence is in the area covered by hospital. Angiographic
- •Vessel size should match available Nobori stent sizes (<4.0 mm, and >2.0 mm by visual assessment).
- •Additional Inclusion criteria (applicable only for France)
- •Patients residence is in the area covered by hospital.
- •Patient is affiliated to social security or equivalent system.
排除标准
- •Pregnancy and women of child bearing potential (less than 50 years of age).
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast material.
- •Diameter Stenosis <30% in the target lesion.
- •The multi-vessel coronary artery disease (DS>50%).
- •Unprotected left main disease with a diameter stenosis of >30% by visual assessment.
- •Distal vessel occlusion.
- •Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter.
- •Fibrinolysis prior to PCI.
- •Known thrombocytopaenia (PLT< 100,000/mm3).
- •Contraindication to PCI, stenting, ASA, clopidogrel.
- •Active bleeding or coagulopathy or patients at chronic anticoagulation therapy.
- •Cardiogenic Shock.
- •Significant comorbidities precluding clinical follow-up (as judged by investigators).
- •Major planned surgery that requires discontinuation of dual antiplatelet therapy.
- •Proximal RCA stenosis (>30%) if the infarct-related artery is mid-RCA or distal-RCA.
- •People under judicial protection.
- •A patient who has congenital heart disease, severe cardiac valve disorder and/or myocardial disease (excluding status post MI).
- •Patient participating in other clinical research study.
结局指标
主要结局
minimal flow area assessed by OFDI
时间窗: at baseline procedure (post-stenting)
Flow area is defined as: (Stent area + incomplete stent apposition area) - (intraluminal defect area attached to the wall + intraluminal defect area free from the wall)
次要结局
- normalised minimal flow area(at baseline procedure (post stenting))
- mean flow area/volume(at baseline procedure (post stenting) and at 6 months)
- intraluminal defect area/volume(at baseline procedure (post stenting) and at 6 months)
- mean stent area/volume(at baseline procedure (post stenting) and at 6 months)
- percent of malapposed struts(at baseline procedure (post stenting) and at 6 months)
- incomplete stent apposition (ISA) area/volume(at baseline procedure (post stenting) and at 6 months)
- percent of struts with coverage(at 6 months)
- healing index(at 6 months)
- tissues prolapse area/volume(at 6 months)
- procedure success(at baseline procedure)
- target vessel failure(at discharge, 1 month, 6 months and 12 months)
- all-cause mortality(at discharge, 1 month, 6 months and 12 months)
- cardiac death, non-cardiovascular death, vascular death(at discharge, 1 month, 6 months and 12 months)
- any myocardial (re)infarction(at discharge, 1 month, 6 months and 12 months)
- target vessel revascularization(at discharge, 1 month, 6 months and 12 months)
- stent thrombosis according to ARC definition(at discharge, 1 month, 6 months and 12 months)
- other serious adverse events (SAEs)(at discharge, 1 month, 6 months and 12 months)