Choosing an Access for Endovascular Treatment of Femoral-popliteal Segment Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Hematoma at the access point
研究概览
简要总结
The aim of this study is to compare the shoulder and femoral approaches used in the endovascular treatment of occlusive lesions of the femoral-popliteal segment of the lower extremity arteries in terms of the frequency of complications. The aim of the study is to answer the following main questions: 1. Does the use of the shoulder approach reduce the overall number of complications compared to the femoral approach? 2. Does the use of the shoulder approach reduce the number of complications requiring surgical intervention compared to the femoral approach? 3. Does the use of a brachial approach reduce the number of technically successful interventions compared to a femoral approach? Researchers will compare the number of complications associated with a brachial approach compared to a femoral approach using closure devices for the revascularization of occlusions in the femoral-popliteal segment of the lower extremity arteries. During the planned revascularization procedure, participants will undergo catheterization of the brachial or common femoral artery. Complications related to radiation therapy will be recorded by doctors within 72 hours after the intervention.
详细描述
The purpose of the study: to compare the complication rate of the shoulder and retrograde femoral access in elderly patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries.
Scientific hypotheses:
- The shoulder access has a lower number of complications compared to the femoral access
- The shoulder access has a lower number of complications requiring surgical intervention compared to the femoral access
- The shoulder access has a comparable % of success of the main intervention with the femoral access Inclusion criteria: arterial diameter at the access site of at least 3 mm, indications for endovascular intervention on the lower extremity arteries, age of 60 years or more, and patient consent to participate in the study.
Exclusion criteria: inability to perform an access due to stenotic lesions of the above-mentioned arteries (common femoral, iliac, axillary, subclavian arteries, brachiocephalic trunk); height more than 180 cm; presence of concomitant pathology limiting the survival of patients; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.), previously performed catheterization through the access artery.
The required sample size was calculated using the M. Blanda method for a study with increased accuracy. The required level of significance (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Femoral and Brachial groups were assumed to be 2% and 9%, respectively. Under these conditions, the estimated sample size was 269 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 283 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •arterial diameter at the access site of at least 3 mm, indications for endovascular intervention on the lower extremity arteries,
- •age of 60 years or more, and patient consent to participate in the study.
排除标准
- •inability to perform an access due to stenotic lesions of the above-mentioned arteries (common femoral artery, iliac arteries, axillary artery, subclavian artery, and brachiocephalic trunk);
- •height exceeding 180 cm;
- •presence of concomitant pathology that limits patient survival; coagulation system pathology (hemophilia, thrombocytopathies, etc.)
- •previous arterial access catheterizations.
研究组 & 干预措施
Brachial
Brachial artery catheterization
干预措施: Brachial artery catheterization (Procedure)
Femoral
Femoral artery catheterization
干预措施: Femoral artery catheterization (Procedure)
结局指标
主要结局
Hematoma at the access point
时间窗: Within 72 hours after artery catheterization
Hematoma at the access point
Acute artery occlusion
时间窗: Within 72 hours after artery catheterization
Acute artery occlusion
Post-catheterization aneurysm that required surgery
时间窗: Within 72 hours after radial artery catheterization
Post-catheterization aneurysm that required surgery
Technical success of access
时间窗: Perioperative/Periprocedural
Technical success of access
Technical success of the index procedure
时间窗: Perioperative/Periprocedural
Technical success of the index procedure
Conversion to another access
时间窗: Perioperative/Periprocedural
Conversion to another access
次要结局
- Total number of complications(Within 72 hours after radial artery catheterization)
- Total number of complications that required surgery(Within 72 hours after radial artery catheterization)
研究者
Aleksandr V. Bocharov, PhD, MD
Clinical Professor, PhD, MD
Pirogov Russian National Research Medical University