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

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.

Study Overview

• Status: Completed
• Conditions: Anomalies Vascular
• Intervention / Treatment: Device: Radifocus guidewire; Device: Silverway guidewire

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Below the shoulder vascular anomaly; If the standard J-tip guidewire does not cross a vascular anomaly located below the shoulder	Device: Radifocus guidewire; The Radifocus guidewire is a hydrophilic coated guidewire that is used when a standard J-tip guidewire does not cross a vascular anomaly
Active Comparator: Above the shoulder vascular anomaly; If the standard J-tip guidewire does not cross a vascular anomaly located above the shoulder	Device: Silverway guidewire; The Silverway guidewire is a newly developed guidewire to overcome the problems the Radifocus guidewire has

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in seconds from introduction to aortic root	Measuring time from entering the guidewire in the catheter to delivery of the catheter to the aortic root (in seconds)	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ability of the study wire to deliver the catheter to the aortic root	If the study wire is able to deliver the catheter to the aortic root	During procedure
Change of access site	Is change of access site necessary?	During procedure
Interventional cardiologists' survey of grading parameters working with the guide wire	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	Directly after procedure. Scale: not satisfactory (1) - somewhat satisfactory (2) - satisfactory (3)

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Koen Ameloot, Dr., Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac catheterization; Radifocus guide wire; Silverway guide wire
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations
• Other Study ID Numbers: Z-2021119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No