ACTRN12620000469910撤回未知
Randomised Control Trial of Vascular Access Site Closure with FemoSeal™ vs StarClose™ - clinical outcomes and imaging features for patients undergoing angiography
orthern Sydney Local Health District0 个研究点目标入组 300 人开始时间: 2020年4月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Participants will be recruited from a population undergoing diagnostic and interventional peripheral vascular procedures. Participants undergoing arterial access via the common femoral artery (CFA) with a 6F or 7F sheath, on a single or dual antiplatelet treatment.
- •These participants will be identified pre operatively by study personnel. They will be invited by one of the researchers to participate in the trial. Patient Information Sheets and Consent Forms will be provided to prospective participants for review prior to obtaining consent. If they wish to participate, written informed consent will be obtained and the patient will be enrolled into the study. Participants will have time to consider and withdraw participation from the time they are informed and/or consented for the trial.
- •Inclusion criteria
- •antegrade or retrograde CFA US guided puncture
- •6F or 7F sheath size
- •CFA diameter >5mm
- •on an antiplatelet agent
排除标准
- •1. acute limb ischaemia
- •2. prior open femoral intervention (ie femoral endarterectomy)
- •3. prior VCD use within 30 days
- •4. heavily calcified vessel not suitable for VCD
- •5. bleeding diathesis
- •6. hypertension with either SBP > 220 or DBP > 110
- •allergy to nitinol or bioabsorable polymer
研究者
相似试验
招募中
不适用
Randomized study of different veins for implantation of pacemaker, defibrillator and resynchronizer cables at Hospital de Clínicas de Porto AlegreHeart failureRBR-6jp2qvHospital de Clínicas de Porto Alegre
已完成
2 期
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular CarcinomaHepatocellular CarcinomaJPRN-UMIN000001384ACE 500 Study Group450
已完成
不适用
A randomised controlled trial of vascular occlusion of the uterine and ovarian arteries at open myomectomy to reduce intra-operative and post-operative blood lossMyomectomySurgeryISRCTN03328551Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)28
已完成
1 期
A randomized controlled trial of intra-arterial infusion of CDDP for hepatocellular carcinoma to prevent intra-hepatic metastasis after curative resectioPatients after curative resection of hepatocellular carcinomaJPRN-UMIN000001138iigata Hepatocellular Carcinoma Therapy Study Group200
已完成
4 期
Randomized controlled trial of endovascular therapy for acute large vessel occlusion with large ischemic coreJPRN-UMIN000034388Department of Neurosurgery, Hyogo College of Medicine200