Clinical Research Directory

A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)

A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis

Investigating the Utility of Augmented Reality Assistance for Ultrasound-Guided Vascular Access

This study will investigate the benefits of augmented reality assistance on ultrasound-guided vascular access. Using the Microsoft HoloLens 2 headset, the investigators will study the benefits of augmented reality technology as a tool for improving the success rate, efficiency, and ease of access for peripheral venous catheters, peripherally inserted central venous catheters, and central venous catheters.

Transulnar Access in Patients With Ipsilateral Radial Artery Occlusion Undergoing Coronary Angiography or Angioplasty

Coronary angiography and angioplasty are commonly performed through the radial artery at the wrist as this approach is associated with fewer bleeding complications and faster recovery. In some patients, the radial artery becomes occluded after prior procedures, requiring selection of an alternative access site for future coronary interventions. The ulnar artery is a potential alternative wrist access. However, limited data are available on the safety of using the ulnar artery in the same arm as an occluded radial artery and on the possible effects on hand strength, sensation, and daily hand function. The goal of this observational study is to evaluate the safety of transulnar access and its effect on hand function in adults with ipsilateral radial artery occlusion undergoing coronary angiography or angioplasty. The main questions addressed by the study are: * How often do serious access-related vascular or nerve complications occur? * Does hand strength, sensation, or functional use of the hand change during follow-up? * Does the ulnar artery remain patent after the procedure? The choice of vascular access site is made by the treating physician based on clinical judgment. Participants who undergo transulnar access will undergo follow-up assessments, including ultrasound evaluation of arm arteries, standardized hand function testing, and short questionnaires assessing upper-limb function. The findings of this study are expected to inform access-site selection, improve patient counseling, and support safer care for patients with radial artery occlusion undergoing coronary procedures.

Single-Needle Distal Return for Long-Term Arteriovenous Fistula Care

Background: For millions of people worldwide with kidney failure, a well-functioning vascular access, like an arteriovenous fistula (AVF), is essential for life-sustaining hemodialysis. However, the standard method requires puncturing the same AVF with two needles three times a week, which over time can damage the vessel, leading to scarring, narrowing, and frequent failures. These complications often require repeated surgical or minimally invasive procedures (reinterventions), causing significant pain, high medical costs, and exhaustion of the patient's limited blood vessels. New Approach: This study will evaluate a modified puncture technique called the Single-Needle Distal Return (SNDR) strategy for long-term AVF care. Instead of using two needles in the AVF, only one needle is placed in the AVF to draw blood. The cleaned blood is then returned to the body through a second needle placed in a superficial vein in the foot or lower leg. This approach aims to reduce trauma to the critical AVF. Study Plan: This is a clinical study conducted at the Blood Purification Center of Anhui Medical University Affiliated Suzhou Hospital. We plan to enroll approximately 50 adult hemodialysis patients who use an AVF and are willing to try the SNDR technique. For comparison, we will also observe data from a similar number of patients receiving standard two-needle AVF care during the same period. The study will last about three years. We will closely monitor patients using the SNDR technique to assess: Effectiveness: Whether dialysis remains adequate (measured by Kt/V). Safety: Rates of complications (like bruising or infection), dialysis machine alarms, and venous pressure during treatment. Practical Benefits: Whether it reduces the need for repair procedures (reinterventions) and hospitalizations related to the AVF. Economic Impact: Changes in healthcare costs. Patient Experience: Patient tolerance and comfort with the technique. We will also analyze the characteristics of patients who successfully use this technique long-term to help identify who might benefit most from it in the future. Potential Significance: If proven successful and safe for long-term use, the SNDR strategy could help protect a patient's precious AVF, potentially reducing painful procedures, lowering costs, slowing down the exhaustion of blood vessels, and improving the quality of life for people on long-term dialysis. The findings may also guide better planning for vascular access care.

StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation

This study, titled aims to compare two vascular closure techniques after catheter ablation for atrial fibrillation (AF). Catheter ablation is a common procedure used to treat AF, but after the procedure, It is important to close the access site in the blood vessel to prevent bleeding. This study will evaluate whether the StatSeal device, a haemostatic disc, can help patients recover more quickly compared to the traditional figure-of-eight suture technique. The primary objective of the study is to determine whether StatSeal reduces the time it takes for patients to start walking after the procedure (known as Time to Ambulation). Secondary objectives include comparing the time to complete haemostasis, discharge eligibility, incidence of adverse events, and patient comfort between the two techniques. Participants in the study will be randomly assigned to receive either the StatSeal device or the figure-of-eight suture after their AF ablation procedure. The study will recruit 160 participants across multiple hospital sites, with 80 participants in each group. Both techniques are standard methods, and participants will be closely monitored for safety throughout the study. By comparing these two closure techniques, the study aims to improve the recovery process for patients undergoing AF ablation and provide evidence on which method leads to better outcomes and patient experiences.

Statseal® for Central Venous Catheter Insertion Sites in Critical Care

All participants in this clinical trial will be undergoing surgery and will have a central venous catheter (also known as a central line) placed in the large vein in the neck as part of their routine care. The purpose of this clinical trial is to compare different ways of dressing central lines. In current standard care, central lines are stitched in place and covered with a protective transparent dressing. This standard care will be compared with the addition of a haemostatic powder beneath the transparent dressing. This powder product aids clotting at the level of the skin, meaning that it prevents or reduces bleeding while helping to maintain a dry and protected environment. The main questions this clinical trial aims to answer are: * Will the addition of a haemostatic powder increase the durability of central line dressings? * What proportion of dressings required an unplanned change? * The reason(s) for any unplanned change * The incidence of bleeding around central line insertion sites * Were any skin problems observed once the dressings were removed? Once the dressings are applied, all central lines sites will be monitored as part of the participant's routine care. Participation in the clinical trial lasts as long as the first central line dressing remains in place. Central line dressings currently and routinely remain in place for up to, but not more than seven days. After this period, there will be no need for any research-related observations. Routine care will continue and will not be affected by the research. Participants will not be asked to make any extra visits over and above those needed for routine care.

PICC Inserted by a Nurse-led Vascular Access Team in Poland

Implantation of PICCs by a trained, dedicated nursing team can be effective and safe, and allows for intravenous therapy that requires medium- to long-term central venous access.

Reduction of Complications Associated With PICC Management

The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care frequency, due to the reduction of device manipulation. A high level of patient satisfaction is detected due to the controlled follow-up of the device care, as well as a decrease in the need for transfer to a center for follow-up. Objective: Identify the type of care frequency for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (thrombosis, phlebitis, accidental removal, obstruction).

Vascular Access Registry

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

Novel Medical Device for Pharmacological Therapy

Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.