Distal Versus Conventional Radial Access for Percutaneous Coronary Interventions (DICON-RADIAL Trial): A prospective randomized trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 874
- 试验地点
- 2
- 主要终点
- The primary end point will be incidence of Radial Artery Occlusion at hospital discharge & at 60 days
研究概览
简要总结
Trans-radial access (TRA) has been established as a safer and superior tofemoral artery access for percutaneous coronary procedures(1–3).This is due to its lower risk of bleeding and vascular complications, as wellas faster post procedure recovery. TRA is associated with better quality oflife and allows safe performance of same-day discharge for diagnostic andinterventional procedures in stable patients, contributing to overallcost-effectiveness(4,5).
Radial artery occlusion (RAO) is by far the most frequent complication ofTRA, with highest incidence in the first 24 hours and spontaneousrecanalization at 30 days in only about one-half of the patients. Itsincidence varies from 0.8 to 10% at 24 hrs and up to 5.5% at 30 days offollow-up(6–10). An occluded radial artery assuch is unsuitable for a future percutaneous coronary or noncoronaryprocedures. In light of the increasing use of TRA in numerous interventionalprocedures, prevention of RAO is becoming a central consideration for achievinga successful radial program.
There is a growing interest in the distal trans radial artery access(dTRA) as an alternative to conventional TRA, with multiple studies reportingfeasibility since its first public introduction in 2017(11).dTRA in the anatomical snuff box or the dorsum of the hand has emerged as apromising alternative access to reduce the risk for RAO because of the puncturesite being beyond the hand anastomotic network, which most likely ensurespersistent blood flow in the radial artery. It has also been shown to beassociated with less pain and lower incidence of compartment syndrome ascompare to TRA and has shown to improve both patient and operator comfort,especially when using the left radial, as there is no disagreeable forearmsupination. Recently publishedrandomized control trials (RCT) have shown striking reductions of RAO afterdTRA compared with conventional TRA(10,12,13),whereas,the multi-centered DISCO RADIAL study did not show a significant difference inRAO, but did demonstrate a significantly shorter hemostasis time with dTRA(7). There is no evidence for or againstthe use of dTRA during PCI from Indian subcontinent.
To further unravel the role of dTRA in current interventional practice inIndia, a prospective, multicenter randomized control trial is planned tocompare the outcomes of dTRA and conventional TRA used for percutaneouscoronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients are at least 18 years of age with palpable proximal and distal radial artery who are planned for percutaneous coronary intervention using 6F radial sheath and guiding catheter.
排除标准
- •1.Patients having clinical instability with compromised hemodynamics.
- •2.ST segment elevation myocardial infarction undergoing primary PCI.
- •3.History of previous coronary angiography or PCI through trans-radial access.
- •4.Chronic kidney disease on maintenance hemodialysis.
- •5.Patient or family refusal.
结局指标
主要结局
The primary end point will be incidence of Radial Artery Occlusion at hospital discharge & at 60 days
时间窗: At hospital discharge & at 60 days
次要结局
- the secondary endpoints will include successful sheath insertion, access-site crossover, access site hematoma, access site bleeding, radial artery pseudoaneurysm, radial artery spasm during procedure, access site related pain according to visual analog scale.(At hospital discharge & at 60 days)
