Combination of InnoSEAL Plus TR Band Compared to TR Band Alone for Radial Artery Outcomes in Patients Undergoing Transradial Coronary Intervention (InnoSEAL II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 2
- 主要终点
- Proportion of patients with Access site combined outcomes
研究概览
简要总结
Angiography or angioplasty are commonly now done through inserting the device through radial artery in hand i.e. trans-radial procedures. It is reported that between 2-30% of these procedures get complicated by radial artery occlusion (RAO) which limit future use of this site for similar procedures if needed. It is important to control the arterial bleeding after the procedure completion while maintaining radial arterial flow appears to be an important factor in reducing RAO (patent hemostasis). Currently the most frequently employed method for hemostasis following trans-radial procedures is a compression device (RCD) such as TransRadial Bands (TRB). But TRB takes hours to achieve hemostasis and causes discomfort to the patients and longer time to discharge. Hemostatic pads offer an alternative to RCD where overall compression time is inherently low and patent hemostasis can possibly be achieved. The combined use of TR band with a hemostatic device may allow ease of use with reduced hemostasis time.
The trial aims to test the hypothesis that compared to TR band (TRB) alone, catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.) used in conjunction with TRB (InnoSEAL+TRB)is nearly as good as TRB alone in terms of the outcomes like RAO and hematoma.
详细描述
It is a prospective, randomized, open label trial with the following study hypotheses (Ha):
- InnoSEAL+TRB is non-inferior to TRB alone in terms of the composite adverse access site outcomes including RAO and hematoma.
- InnoSEAL+TRBis non-inferior to TRB alone when comparing ease of use scores rated by the cath lab technicians.
- InnoSEAL+TRB is superior to TRB alone for outcomes of reduction in total hemostasis time, total observation time for the radial site and time to hospital discharge for daycare patients sub group.
- InnoSEAL+TRBis superior to TRB alone in terms of minimized patient discomfort.
Sample size:
Keeping a combined complication rate of 17.7% (RAO:7.7%, Hematoma: 10%), difference in favor of the experimental treatment of 4.89%, power of 80%, one sided alpha of 2.5%, 10% attrition rate, a sample of at least 357 patients in each group and a total of 714 patients will be required.
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Adult patients of both gender undergoing coronary procedure using trans radial approach (diagnostic or PCI) will be included
- •Both elective and hemodynamically stable, acute coronary syndrome (ACS) patients will be included.
排除标准
- •Sheath larger than 6F
- •IV Heparin or GP 2b/3a inhibitors continued after the procedure
- •Ongoing anticoagulation with Warfarin or Rivaroxaban or INR > 3
- •Ipsilateral AV fistula
- •Barbeau's Class D
- •History of RAO at baseline
- •Patients unable to give consent due to clinical instability or sedation.
结局指标
主要结局
Proportion of patients with Access site combined outcomes
时间窗: within 24 hours
Proportion of patients with RAO and/or hematoma of any grade. 1. Radial artery occlusion: Radial artery will be defined as occluded if reverse Barbeau's test shows absence of flow on pulse oximetry just after the removal of the TR band in both groups.In patients identified to have RAO, findings will be confirmed using UltraSound (US) Duplex using color flow with pulse wave imaging within 24 hours of the radial procedure.US Duplex will be performed during the index hospital stay. 2. Radial Hematoma: Radial artery site will be assessed for presence of hematoma at the end of hemostasis protocol. Hematoma will be marked if present, and graded according to categories of I-IV. Hematomas grade II-IV will be considered significant.
次要结局
- Ease of use(Upto 30 weeks)
- Total observation time:(within 24 hours)
- Time to hospital discharge: (For daycare patients only)(within 24 hours)
- Total compression time:(within 24 hours)
- Patient discomfort:(within 24 hours)