Skip to main content
OpenTrials
Completed

NCT Number: NCT05231889

Radifocus (Terumo) Versus Silverway (Asahi) to Deliver Catheters During Cardiac Catheterization

In some cases the standard J-tip guidewire cannot deliver the catheter into the aortic root, because of arterial loops or spasm. In these cases a hydrophilic guidewire (Terumo) gives the right lubricity and good shape retention to guide the catheter through the artery. However, the Terumo wire does not give much torque and could therefore easily penetrate side branches and cause dissection or perforation. The latest Silverway guidewire has some new advantages which is easier to guide and could cause less complications while faster delivery of catheters to the aortic valve. The investigators aim to compare both guide wires.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

About this study

During cardiac catheterization a catheter is threaded through the radial arteries to the aortic root with the support of a guide wire. The standard workhorse to deliver the catheter is a J-tip guidewire (spring coil wire). However, in patients with arterial tortuosity or spasm, this guidewire has low lubricity and no torque to direct the catheter because the outer coil and core are not connected together.

If this problem is encountered, interventional cardiologists will use a hydrophilic polymer-coated guide wire. Up to date there are several hydrophilic coated guide wires available. One of these is the Radifocus Guide Wire M (Terumo, Japan). Although it has better torque transmission than the spring wire, it still has low torque transmission due to a Nitinol core structure, is less supportive and can easily enter side branches because of the high lubricity and therefore might cause dissections or perforations.

In some cases, coronary angioplasty guide wires are needed to negotiate a highly tortuous artery, but they lack the support to advance the catheter.

Recently, the Silverway Guide Wire has been created (Asahi Intecc Co, LTD., Japan) to overcome the problems that a spring- and polymer wire have. Features that this new guide wire provide is hybrid coating and ACT ONE technology that connects the wire core and coil to ensure one to one torque transmission The investigators aim to compare both guide wires in deliverability, workability and complication rate.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for radial artery access for diagnostic cardiac catheterization
  • Being able to receive the per standard protocol Verapamil and Nitroglycerin administration via radial artery
  • Not able to deliver a diagnostic or guiding catheter to the aortic root by means of the standard J tip wire
  • No signs of early complication after initial attempt with the J tip wire such as dissection, perforation or hematoma
  • Age ≥ 18 years

Exclusion criteria

  • Femoral or brachial artery access
  • Patients with known CREST syndrome or other forms of scleroderma
  • Emergent indication for cardiac catheterization such as an acute coronary syndrome

Treatment and study plan

Silverway guidewire

Device

The Silverway guidewire is a newly developed guidewire to overcome the problems the Radifocus guidewire has

Radifocus guidewire

Device

The Radifocus guidewire is a hydrophilic coated guidewire that is used when a standard J-tip guidewire does not cross a vascular anomaly

Primary outcomes

  1. Time in seconds from introduction to aortic root

    Time frame: During procedure

    Measuring time from entering the guidewire in the catheter to delivery of the catheter to the aortic root (in seconds)

Secondary outcomes

  1. The ability of the study wire to deliver the catheter to the aortic root

    Time frame: During procedure

    If the study wire is able to deliver the catheter to the aortic root

  2. Change of access site

    Time frame: During procedure

    Is change of access site necessary?

  3. Interventional cardiologists' survey of grading parameters working with the guide wire

    Time frame: Directly after procedure. Scale: not satisfactory (1) - somewhat satisfactory (2) - satisfactory (3)

    The interventional cardiologist who used the study wire must fill up a survey after procedure to grade the workability and deliverability of the study wire

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Acronym: RADVES

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2022
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.