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临床试验/NCT06942260
NCT06942260招募中不适用

Vascular Access Registry (VARegistry) - Prospective Registry of Vascular Access

University Hospital of Patras1 个研究点 分布在 1 个国家目标入组 1,157 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,157
试验地点
1
主要终点
Percentage of success of the puncture at the initial access point

研究概览

简要总结

The Vascular Access Registry (VARegistry) is a prospective patient registry that will be conducted at the Hemodynamic Laboratory of the Cardiology Clinic of the University General Hospital of Patras.

The puncture of the vessel will be performed either using palpation, anatomical landmarks or using ultrasound guidance, depending on the ability and preference of each operator. Patients who meet all admission criteria and no exclusion criteria will be admitted to the study.

Patients >18 years of age presented with indication for any percutaneous cardiac procedure will be included in the study. No exclusion criteria exist.

The vascular puncture will be performed according to current guidelines and on the basis of recent scientific data. If the attempt to obtain access from the selected location is unsuccessful, the access location will be changed. The choice of the new access location in case of failure of the originally selected one is subject to the preference of each operator.

Participants will be monitored for the period they remain hospitalized, depending on the initial indication of intervention, and a follow-up with a vascular ultrasound after one month is recommended.

The primary endpoint is the percentage of success of the puncture at the initial access point.

The secondary endpoints are as follows:

  • Percentages of successful puncture of vascular access with and without the use of ultrasound guidance

  • Occlusion rate of the access artery before discharge

  • Crossover rate of access site during procedure

  • Time to sheath placement during procedure

  • Total intervention time

  • Procedure duration (from the sheath insertion to the completeness of the procedure)

  • Total fluoroscopy time

  • Total DAP (Dose area product)

  • Air Kerma

  • Time required for hemostasis

  • Vascular complications *

  • Classification of hematomas (modified classification by EASY)**

  • Vascular implication of access artery using ultrasound monitoring of patients at 30 days

  • VARC criteria ** if the forearm has been used

详细描述

A. Introduction Ensuring vascular access is a prerequisite for coronary angiography and/or angioplasty (Percutaneous Coronary Intervention - PCI), and for transcatheter aortic valve replacement (TAVR). Femoral access has been the established access route for several decades regarding coronary interventions and currently for structural heart disease, mainly due to the size of the sheaths. However, due to increased vascular complications, speaking mostly for coronary interventions, alternative access routes with additional benefits have been sought. In this context, the brachial artery and the ulnar artery were tested without the expected results, while the radial artery presented the most favourable characteristics and was eventually established as the main access route. Recent guidelines from the European Heart Society (ESC), the American College of Cardiology (ACC), American Heart Association (AHA) and the Society for Cardiovascular Angiography and Interventions (SCAI) recommend the TransRadial Approach (TRA) for both acute and chronic coronary syndromes, as well as complex coronary interventions.

Recently, an alternative transradial approach through the anatomical snuffbox has been proposed. Large, randomized studies have shown that the distal TransRadial Approach (dTRA) is a safe method, with faster hemostasis time and lower rates of obstruction of the radial artery. (Radial Artery Occlusion - RAO). Initially, it was shown that dTRA reduces the rate of RAO in the forearm, compared to TRA in the first 1-30 days after intervention. Then, the lower rate of RAO in the dTRA group was confirmed, and the significantly less time required for haemostasis in the dTRA access group was highlighted. The most recent, multicenter study, DISCO-RADIAL, did not show a statistically significant advantage in avoiding RAO when using dTRA, however, it should be noted that RAO prevalence was less than 1% in both access sites.

Both studies showed a lower risk of EASY ≥II hematoma, but ANGIE study showed a statistically significant difference in the incidence of hematomas at the puncture site using a modified EASY scale. There was consensus both on the frequency of crossover of access site from dTRA, and on the longer duration required for gaining access of the dTRA.

A common point of the randomized studies that have been conducted so far is the exclusion of patients with ST-elevation myocardial infarction (STEMI), as the safety and effectiveness of the technique had to be firstly demonstrated, and when the necessary experience was acquired in more stable clinical contexts, it could then be tested in more urgent situations. Similarly, in the case of TRA, STEMI patients were the last framework in which its superiority over the femoral access was proven. Limited data exists to date on the use of dTRA in patients with STEMI, and those are derived from retrospective and prospective studies. In addition, non-randomized studies have shown that dTRA is a reliable alternative to TRA and femoral approach in the emergency setting. Nevertheless, no randomized studies have yet been published comparing dTRA with TRA in STEMI patients.

Despite the increasing use of transradial access and consequential reciprocal reduction in femoral access use for coronary angiography and PCI, femoral access remains necessary for numerous procedures, many of which require large-bore access. The transfemoral approach is the preferred and most commonly used access for transcatheter aortic valve replacement. Femoral access is used in most cases of mechanical circulatory support, such as in the setting of cardiogenic shock, cardiac arrest, or high-risk PCI with such devices as intra-aortic balloon pump, Impella (Abiomed, Danvers, Massachusetts), or venoarterial extracorporeal membrane oxygenation. Additionally, femoral access is preferred for some complex coronary interventions, such as coronary chronic total occlusion PCI.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Indication for percutaneous cardiac procedure

排除标准

  • No exclusion criteria exist

结局指标

主要结局

Percentage of success of the puncture at the initial access point

时间窗: From puncture of access site until successful sheath insertion

次要结局

  • Percentages of successful puncture of vascular access with and without the use of ultrasound guidance(Until successful sheath insertion)
  • Occlusion rate of the access artery before discharge(From the completion of procedure until hospital discharge)
  • Crossover rate of access site during the procedure(From first puncture of primary access site until successful sheath insertion)
  • Time to sheath placement(From first puncture of primary access site until successful sheath insertion)
  • Total intervention time(From first puncture of primary access site until successful completion of the procedure)
  • Procedure duration(From the sheath insertion to the completeness of the procedure)
  • Total fluoroscopy time(From the sheath insertion to the completion of the procedure)
  • Total DAP (Dose area product)(From the sheath insertion to the completion of the procedure)
  • Air Kerma(From the sheath insertion to the completion of the procedure)
  • Time required for hemostasis(From the application of any hemostasis device until hemostasis is achieved)
  • Type and rate of vascular complications before discharge(From the start of the procedure until hospital discharge)
  • Classification of hematomas(From the start of the procedure until hospital discharge)
  • Type and rate of vascular implications of access artery using ultrasound monitoring until follow-up(From the start of the procedure until 30-day follow up)

研究者

发起方
University Hospital of Patras
申办方类型
Other
责任方
Principal Investigator
主要研究者

Grigorios Tsigkas

Associate Professor of Cardiology

University Hospital of Patras

研究点 (1)

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