TACTIC Coronary Thrombus Aspiration With Cath Rx In Anterior Myocardial Infarction: A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ceric Sàrl
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Microvascular obstruction
研究概览
简要总结
The aim of this study is to evaluate the impact of sustained thrombectomy with INDIGO ASPIRATION SYSTEM using CAT RX versus no thrombectomy during primary percutaneous coronary intervention (PPCI) on microvascular obstruction and infarct size, as measured by cardiovascular magnetic resonance (CMR) between 3 and 5 days post PPCI, in patients with anterior STEMI
详细描述
Prospective, randomized 1:1, controlled, open label, multicentred, investigator initiated clinical investigation in 14 European sites. 140 patients will be enrolled in the study after coronary angiography confirming prox or mid LAD occlusion. Patients will be randomised in one of the following arms:
Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX as previously described.
Control arm: Subjects randomized to the control arm will be treated with standard PPCI .
Participants will undergo a cardiac MRI, including gadolinium contrast imaging, within 3-5 days following the index procedure. If clinical contraindications prevent the MRI from being performed within this timeframe, it should be conducted as soon as the participant is clinically stable.
After the discharge, In-person or phone follow-ups will take place at 30 days, and 12 months post-PCI.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 and <75 years old
- •Acute anterior STEMI with ≥2 mm in two (2) or more contiguous anterior leads or ≥4 mm total ST-segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
- •Culprit lesion proximal or mid LAD at coronary angiography
- •TIMI thrombus grading > 3 or TIMI flow 0 after guidewire crossing the lesion.
- •Patient presents to the hospital between 1 - 6 hours of ischemic pain onset
- •Patient indicated for primary percutaneous coronary intervention (PPCI)
排除标准
- •Unable to give Informed consent.
- •Life expectancy < 1 year.
- •Contraindication to PCI
- •STEMI due to stent thrombosis
- •Spontaneous coronary aretery dissection
- •Patient undergone any kind of maneuvers to restore flow before randomization
- •Unwitnessed cardiac arrest OR ≥30 minutes of cardiopulmonary resuscitation (CPR) prior to enrolment OR any cardiac arrest with impairment in mental status, cognition or any global or focal neurological deficit
- •New onset of stroke symptoms and NIHSS >2, prior to index procedure
- •Known intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media.
- •Active severe bleeding
- •Severe hepatic/kidney impairment
- •Administration of fibrinolytic therapy within 24 hours prior to enrolment
- •Cardiogenic shock defined as systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg), plus one (1) of the following: any requirement for pressors / inotropes prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion, or use of IABP or any other mechanical circulatory support device
- •Inferior STEMI or suspected right ventricular failure
- •Severe valvulopathy
- •Acute cardiac mechanical complication: LV-free wall rupture OR interventricular septum rupture OR acute mitral regurgitation
- •Medical Conditions & History:
- •Suspected or known pregnancy
- •Suspected systemic active infection
- •History or known hepatic insufficiency prior to catheterization
- •Undergoing a renal replacement therapy
- •Chronic obstructive pulmonary disease (COPD) with home oxygen therapy or on chronic steroid therapy
- •Contraindication to perform MRI or use gadolinium [creatinine clearance (CrCl) <30 mL/min, non-compatible implant, claustrophobia]
- •Cardiovascular history
- •Known or evidence of prior MI, including pathologic Q-waves in non-anterior leads
- •Prior coronary artery bypass graft surgery (CABG) or LAD PCI
- •History of heart failure (documented history of EF <40% or documented hospitalization for HF within 1 year prior to screening
- •Prior aortic valve surgery or TAVR
- •Left bundle branch block (new or old)
- •History of stroke/TIA within 3 months prior to screening
研究组 & 干预措施
Subjects randomized to the control arm will be treated with standard PPCI
Subjects randomized to the control arm will be treated with standard PPCI
- Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX
Treatment arm: Subjects randomized to the treatment arm will be treated with the CAT RX
结局指标
主要结局
Microvascular obstruction
时间窗: Within 3-5 days post procedure
Incidence of Microvascular obstruction (MVO) assessed by Cardiac Magnetic Resonance
次要结局
- Secondary CMR endpoint:(Within 3-5 days post procedure)
- Secondary exploratory clinical and angiographic endpoint:(At the end of the procedure)
- Safety endpoint(At 1 month post procedure)
- Safety endpoint(At 1 year Follow Up)