NCT04339699招募中不适用
STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke
Nobles Medical Technologies II Inc2 个研究点 分布在 2 个国家目标入组 640 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Effective PFO closure rate of the NobleStitch EL
研究概览
简要总结
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.
详细描述
To demonstrate the non-inferiority of the NobleStitch™ EL with medical management in both safety and effectiveness compared to the FDA-approved Amplatzer Occluder with medical management for PFO Closure.
To demonstrate that the NobleStitch EL does not increase the incidence of ischemic stroke compared to published medical management data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female ages 18 - 60 years old
- •A PFO and a Cryptogenic Stroke verified by a neurologist
- •Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:
- •Symptoms persisting ≥24 hours, or
- •Symptoms persisting <24 hours with Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct
- •Cryptogenic stroke was defined as a stroke of unknown cause
- •Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required)
- •Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE).
- •Hypercoagulable state assessment to rule out an underlying hypercoagulable state
排除标准
- •Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
- •Age <18 or > 60 years of age
- •Previous myocardial infarction or unstable angina within 6 months
- •Clinically significant mitral or aortic valve stenosis or severe regurgitation
- •Left Ventricular Ejection Fraction <50 percent
- •Progressive neurological dysfunction or reduced life expectancy
- •Contrast allergy
- •Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases
- •Active Endocarditis
- •Perspective participants with known causes of Ischemic Stroke
- •Arterial dissection
- •Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants
- •Perspective participants with prosthetic heart valves
- •Uncontrolled diabetes Mellitus
- •Pulmonary hypertension
- •Uncontrolled systemic hypertension
- •Intracranial pathology
- •Neurological deficits not due to stroke that may affect neurologic assessments
- •Active autoimmune disease
- •Active infection
- •Alcohol and/or drug abuse
- •A requirement for chronic anticoagulation therapy that cannot be discontinued
- •Anatomic features (inability to achieve vascular access)
结局指标
主要结局
Effective PFO closure rate of the NobleStitch EL
时间窗: 6 months
Effectiveness PFO closure rate of NobleStitch EL suture mediated closure with medical management compared to Amplatzer PFO occluder with medical management for PFO closure. Effective PFO closure rate defined as Grade 0 or 1 shunt at rest and during Valsalva at 6 month post closure attempts
次要结局
- Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL(5 years)
研究者
研究点 (2)
Loading locations...
相似试验
终止
不适用
Slotted Hole Versus Fixed Hole C-TekHerniated DiscRadiculopathySpondylolysisNCT00585923Zimmer Biomet115
终止
不适用
A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps TenodesisBicep TendinitisBiceps Tendon DisorderTenosynovitis BicepsNCT03529162St. Louis University4
已完成
不适用
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral FracturesTrochanteric and Subtrochanteric Hip FracturesTreatment With a New Nail or a Sliding Hip ScrewNCT00621088Haukeland University Hospital500
招募中
不适用
Stapler Reinforcement Patches Compared to Standard Staplers in GastrojejunostomyGastrostomyAnastomotic LeakagePostoperative ComplicationsGastric CancerNCT06464978Nanchong Central Hospital382
已完成
不适用
A prospective, randomised multicentre study comparing cervical anterior discectomy without fusion, with fusion or with arthroplastyCervical disk herniation with radiculopathyMusculoskeletal DiseasesISRCTN41681847Canisius-Wilhelmina Hopsital (CWZ) (The Netherlands)270