SIMultaneous Urgent Cardiac Surgery and Endovascular Stroke Prevention Using the Micronet-covered CGUARD Stent in Hemodynamically Compromised Patients at Increased Peri-operative Stroke Risk: SIM-GUARD Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
研究概览
简要总结
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and/or valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study.
Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.
详细描述
The coexistence of symptomatic or unstable stroke-threatening carotid atherosclerotic stenosis with cardiac disease requiring urgent / fast-track cardiac surgery (such as advanced unstable or multivessel coronary artery disease, recent myocardial infarction or pulmonary edema, severely impaired myocardial contractility, and/or severe valvular disease requiring surgical treatment) represents a major medical and therapeutic/logistics challenge.
According to current guidelines, in absence of prospective randomized evidence, the most appropriate management strategy for a given patient should be determined by a multispecialty team. In hemodynamically compromised patients sequential treatment (i.e., first carotid stenosis repair followed by surgery or first cardiac surgery followed by carotid stenosis treatment, either surgical or endovascular) is associated with a high risk of cardiac complications in case of first-stage carotid stenosis treatment and a high risk of neurological complications in case of the first-stage cardiac surgery.
In this challenging patient group, we have introduced single-stage, truly simultaneous procedure. The fundament of the strategy is to establish extracorporeal circulation back-up ("CEC standby") prior to the minimally invasive (endovascular) treatment of stroke-threatening carotid artery stenosis in the hybrid room under single anesthesia.
For CAS (proximal or distal protected), in case of suboptimal femoral access (or lack of femoral access), a direct access via carotid artery is used (transcervical or transcarotid revascularization), this is immediately followed by cardiac surgery.
The procedure, each time, follows recommendation of the Multispecialty Team (Heart Team + NeuroVascular Team) as the lowest-deemed risk management in patients with indications for both urgent both carotid revascularization and cardiac surgery. Both carotid and cardiac treatment are performed under single anesthesia with the feasibility of immediate extracorporeal circulation support during carotid revascularization in case of hemodynamic collapse.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients eligible for concomitant carotid artery stenting in conjunction with cardiac surgery based on Heart Team and NeuroVascular Team reccomendation and according to local standards of practice.
- •Signed informed consent form
- •Consent to (routinely performed in this group of patients) follow-up visits and tests performed (routinely) during long-term follow-up
- •De novo atherosclerotic lesions or neo-atherosclerosis.
- •Symptomatic patients (with a history of ipsilateral transient cerebral ischemia, stroke or amaurosis fugax within the past 6 months) with carotid artery stenosis ≥50% as assessed by NASCET angiography or
- •Asymptomatic patients with carotid artery stenosis ≥70-80% as assessed by angiography (NASCET method).
- •Coronary angiography-confirmed multivessel disease or left main stem stenosis with the symptoms of unstable angina or non-ST-segment elevation myocardial infarction.
- •Severe symptomatic valvular disease detected by echocardiography.
排除标准
- •Expected survival time <1 year (e.g., cancer).
- •Renal failure with GFR < 20 ml/min/1.73 m2 as calculated by the CKD-EPI formula
- •Women who are pregnant (pregnancy test).
- •Coagulopathies.
- •History of hypersensitivity to a contrast agent that does not respond to pharmacotherapy.
- •Total carotid artery occlusion.
- •Stent in the carotid artery that protrudes into the aortic arch.
- •Anatomic variants that preclude stent implantation.
- •Significant stenosis of the common carotid artery proximal to the target lesion.
- •Mobile atherosclerotic plaques in the aortic arch.
- •Anatomy of the coronary arteries unsuitable for bypass grafting.
- •Lack of available vascular material for grafting.
- •Porcelain aorta.
结局指标
主要结局
Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days
时间窗: 30 days from index procedure
Freedom from any death, any stroke, and myocardial infarction at 30-day follow-up
次要结局
- Rate of ipsilateral stroke in the first year(From 31 days till 365 days post-procedure)
- Clinical success(Day 2 after procedure)
- Rate of ipsilateral stroke up to 5 years(From 1 year till 5 years post-procedure)
- Rate of arterial access complications(Up to 24 hours post-procedure)
- Freedom from major clinical complications comprising MACNE at 6 months(At 6 months from index procedure)
- Freedom from major clinical complications comprising MACNE at 12 months(At 12 months from index procedure)
- Procedural success rate for carotid stenting(Periprocedural)
- Technical success(At the procedure completion)
- Rate of cardiac surgery related complications(Up to 24 hours post-procedure)
- Rate of other major peri-procedural complications(Up to 7 days post-procedure)
- Rate of any stroke up to 5 years(Untill 5 years post-procedure)
- Stroke free survival rate up to 1 year(Untill 1 year post-procedure)
- Ipsilateral stroke free survival rate up to 1 year(Untill 1 year post-procedure)
- Stroke free survival rate up to 5 years(Untill 5 year post-procedure)
- Ipsilateral stroke free survival rate up to 5 years(Untill 5 year post-procedure)
- Rate of coronary or carotid restenosis(Untill 5 year post-procedure)
- Rate of cardiac or carotid reintervention(Untill 5 year post-procedure)
- Ultrasound Evaluated Carotid Artery Velocities(After procedure and at 12 months follow up)
- Recurrence of angina or valvular heart disease at 30 days and 12 months(At 30 days and 12 months after surgery)
- Recurrence of angina or valvular heart disease up to 5 years(Up to 5 years thereafter after surgery)
- Feasibility of combined treatment(At the procedure completion)