NCT00516308终止2 期
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
FoxHollow Technologies2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system. The primary endpoints are correlation between OCT images and histological characterization of excised tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires treatment for peripheral arterial disease (PAD).
- •Patient is willing and able to provide Informed Consent.
- •Patient has at least one focal, de novo infrainguinal lesion in a native vessel.
- •The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used.
- •The lesion is ≥ 50% stenosed by quantitative vascular angiography.
- •The lesion is ≤ 7 cm in length.
- •The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy.
排除标准
- •Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate.
- •The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified.
- •Patient presents with concomitant disease contraindicating an endovascular intervention.
- •Patient is pregnant.
- •The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter SurvivalPeripheral Intravenous Vein Catheter PhlebitisIntravenous InfectionNCT06107361Corewell Health East360
撤回
不适用
Evaluating the Role of the Guidewire in Peripheral Intravenous AccessPeripheral Intravenous Vein Catheter PhlebitisIntravenous InfectionNCT04949854Corewell Health East
已完成
不适用
Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon AngioplastyCardiovascular DiseasesNCT02725307Tampere University Hospital30
已完成
不适用
Correlation of Physical Exam Versus Non-invasive Assessment Versus Invasive Assessment of Central Venous PressureCentral Venous PressureNCT01574690Mespere Lifesciences Inc.50
尚未招募
不适用
Perioperative validation of the non-invasive hemodynamic measuring device TL-400hemodynamic changes, low blood pressure, fluid challenge, vasopressant/inotropic agent administration, measurement cardiac output, measurement blood pressure, non invasive cardiac output measurement. hemodynamische veranderingen , vocht bolus, cardiac output meting, bloeddruk meting, non invasieve cardiac output metingNL-OMON26680Radboud university medical centre20