Evaluating the Safety and Efficacy of Radial Access for Abdominopelvic Vascular Intervention: a Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,143
- 试验地点
- 1
- 主要终点
- Technical success rate: radial artery puncture success rate and procedure success rate
研究概览
简要总结
To evaluate the safety and efficacy of R.A.V.I.(radial access for abdominopelvic vascular intervention), and evaluate the feasibility and safety of repeated radial artery intervention
详细描述
This is a prospective, multicenter clinical study with 1143 patients scheduled to enroll based on data from 10 hospitals for any abdominopelvic vascular intervention that can be performed via a radial approach。 The investigators conducted abdominopelvic vascular interventional therapy via radial artery approach according to the lesions and conditions of the subjects.
All subjects underwent Barbeau tests before surgery to examine the flow traffic of the radial and ulnar arteries, and to measure the diameter of the radial artery (inner diameter) by Doppler ultrasound to evaluate its compatibility with the outer diameter of the vascular sheath.
All enrolled subjects were followed up within 24 hours and 1 month after unsheathing to observe the clinical outcome of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age ≥18 years old, gender is not limited;
- •Patients who need abdominopelvic transarterial interventions
- •Preoperative ultrasound assessment of radial artery diameter ≥2mm;
- •Those with good radial pulse and normal Barbeau test (non-D wave);
- •There was no infection, redness swelling or ulceration near the puncture site;
- •Patients and(or) family members agreed to participate in the clinical study and signed informed consent
排除标准
- •Has a history of severe allergy or intolerance to contrast media or chemotherapy drugs;
- •Absence or occlusion of the radial artery pulse;
- •Need large sheath (≥6Fr);
- •Previous history of stroke;
- •Patients with chronic kidney disease who need to establish dialysis access or preserve upper limb blood vessels in the future;
- •Previous history of interventional procedure through radial artery approach (re-intervention of enrolled patients is not included);
- •The investigator believes that the aortic calcification is severe. and the risk of plaque detachment is existed;
- •Patients and(or) family members do not agree to join the clinical trials and sign the informed consent ;
- •According to the investigator's judgment, there are other conditions that are not suitable for participating in this clinical study.
结局指标
主要结局
Technical success rate: radial artery puncture success rate and procedure success rate
时间窗: up to 1 day after surgery
1)The definition of successful puncture: the radial artery sheath is inserted into the radial artery; 1. The definition of successful puncture: the radial artery sheath was inserted into the radial artery; 2. The definition of successful procedure: the catheter was inserted into the target blood vessel via the radial artery, the target procedures was completed, and no crossover to other approach;
Puncture success rate and procedure success rate of repeated radial artery intervention
时间窗: up to 1 day after surgery
Repeat radial artery intervention: two or more procedures in the same patient with ipsilateral radial artery intervention.
Complications related to radial approach
时间窗: up to 1 month after surgery
a) Minor complications: such as radial artery pulse weakening or disappearance without evidence of distal ischemia, local hematoma\* formation or bleeding without blood transfusion or surgical intervention, radial artery spasm\*, etc. i. Asymptomatic or mild symptoms, no treatment, no sequelae; ii. Minor treatment, including overnight observation only, without sequelae; b) Major complication: Such as the need for blood transfusion, limb ischemia, pseudoaneurysm\*, any complications requiring surgical intervention, etc. i. Short-term hospitalization (\<48 hours) ii. Unexpected level of care escalation, prolonged hospital stay(\>48 hours) iii. Permanent damage; iv. Die;
次要结局
- Radial artery puncture and sheath insertion time;(up to 1 day after surgery)
研究者
Gao-jun Teng
President
Zhongda Hospital