SILK ROAD™ MEDICAL EMBOLIC PROTECTION SYSTEM: FIRST IN MAN STUDY "The PROOF Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Safety Evaluation as Composite of Occurrences of Major Stroke, Myocardial Infarction and Death
研究概览
简要总结
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris that is liberated during stenting, pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed.
Cerebral protection with carotid flow reversal is a method that was developed by Parodi, et al., as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Criado, et al., developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach. Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.
详细描述
Carotid artery disease is known to increase the risk of neurologic consequences such as transient ischemic attacks (TIA), ischemic stroke, or death due to the release of embolic particles in the vessels supplying the brain. Two principal treatments, carotid endarterectomy (CEA), and carotid artery stenting (CAS), are used to treat this disease. Embolic protection devices, both distal filters and occlusive devices, are employed during the CAS procedure to reduce the risk of carotid plaque embolus secondary to instrumentation during carotid intervention. Existing embolic protection devices are placed using a transfemoral approach and thus have potential for particle embolization while crossing the aortic arch, supraaortic trunk and the carotid lesion before cerebral protection is in place. Other limitations of these devices include the potential for carotid intimal injury, dissection or spasm during deployment, and release of emboli during retrieval.
Noting that carotid embolization remains the "Achilles heel" of carotid artery stenting, an alternative approach to embolic protection was developed by Juan Parodi. The system works by balloon occlusion of the common carotid artery and external carotid artery. An arteriovenous fistula is created with sheaths and catheters and provides retrograde (reverse) blood flow from the internal carotid artery (ICA) and the common carotid artery (CCA) to the femoral vein.
Embolic particles released during CAS pass retrograde through a catheter into a 180 micron filter before the blood re-enters the venous system. (Parodi, Ferreira et al. 2005) A variation of the reverse flow approach utilizing a surgical, transcervical approach to the carotid artery was developed to address challenges and risks associated with the placement and use of existing embolic protection devices. Criado et al. (2004) describe the use of flow reversal during CAS via a transcervical surgical cutdown, access and proximal occlusion of the CCA and establishment of a carotid artery - internal jugular (IJ) vein fistula. (Criado, Doblas et al. 2004).
A difference between the transfemoral-based Parodi approach and the transcervical-based Criado approach is the removal by Criado of the ECA occlusion step. In the Criado approach, the procedure is designed such that the flow is reversed in both the internal and the external carotid arteries, whereas in the Parodi procedure, flow reversal occurs only in the ICA. Another difference in the Criado system is the shorter length and larger diameter tubing afforded by the transcervical approach. The rate of flow reversal enabled by the Criado arteriovenous shunt is higher and is designed to overcome the potential for antegrade flow from the ECA to the ICA.
However, as reported by both Parodi and Criado, active aspiration is often utilized during critical periods of the procedure, to guarantee robust reversal of flow in the ICA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be > 21 years of age.
- •Subject has the ability to understand and cooperate with study procedures and agrees to return for all required follow-up visits, tests and exams.
- •Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted to therapeutic dose after the procedure.
- •The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local medical ethics committee (EC).
- •The life expectancy of the subject is at least one year.
- •The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved.
- •The subject must have a minimum distance of 5 cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound, computed axial tomographic (CT) angiography or magnetic resonance (MR) angiography.
排除标准
- •The subject was participating in another investigational trial that would interfere with the conduct or result of this study.
- •The subject had dementia or a neurological illness that may confound the neurological evaluation.
- •Presence of any one of the following anatomic risk factors:
- •Previous radiation treatment to the neck or radical neck dissection
- •Tracheostomy or tracheal stoma
- •Laryngectomy
- •Contralateral laryngeal nerve palsy
- •Severe tandem lesions
- •Inability to extend the head due to cervical arthritis or other cervical disorders
- •A total occlusion of the target vessel.
- •There was an existing, previously placed stent in the target artery.
- •The subject had a known life-threatening allergy to the contrast media that cannot be treated.
- •Subject had history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalrudin (Angiomax™). Subject was unable to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.
- •The subject had a GI bleed that would interfere with antiplatelet therapy.
- •The subject had known cardiac source of potential emboli.
- •Subject had a Hemoglobin (Hgb) level less than 8 gm/dL (unless on dialysis), platelet count < 50,000/mm3, or known heparin associated thrombocytopenia.
- •Subject had documented atrial fibrillation in the 90 days prior to the procedure.
- •The subject had a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an Activated Clot Time (ACT) at > 250, or will refuse blood transfusion.
- •The subject had atherosclerotic disease involving in the ipsilateral common carotid artery that precluded safe placement of the arterial sheath.
- •The subject has other abnormal angiographic findings that indicate the subject is at risk for a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
- •There is evidence of a carotid artery dissection prior to the initiation of the procedure.
- •There is an angiographically visible thrombus.
- •There is any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure > 180 mm Hg, tortuosity, occlusive disease, vessel anatomy, aortic arch anatomy, or cerebral protective system.
- •Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
- •There is evidence of bilateral carotid stenosis that would require intervention within 30 days of procedure.
- •There is evidence of a stroke within the previous 30 days of the procedure.
- •There is a planned treatment of a non-target lesion within 30 days post procedure.
- •There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
- •There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the procedure.
- •Female subjects who are pregnant or may become pregnant.
结局指标
主要结局
Safety Evaluation as Composite of Occurrences of Major Stroke, Myocardial Infarction and Death
时间窗: 0 days post-procedure to 30 days post-procedure
Safety will be evaluated as a composite of major stroke, myocardial infarction and death during the 30-day post procedural period.
次要结局
- Number of Participants Demonstrating Acute Device Success, Procedural Success, and Tolerance to Reverse Flow(peri-operative to 30 days post-procedure)