Radifocus (Terumo) Versus Silverway (Asahi) to Deliver Catheters During Cardiac Catheterization (RADVES)
Primary Purpose
Anomalies Vascular
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Silverway guidewire
Radifocus guidewire
Sponsored by
About this trial
This is an interventional supportive care trial for Anomalies Vascular focused on measuring Cardiac catheterization, Radifocus guide wire, Silverway guide wire
Eligibility Criteria
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
Sites / Locations
- Ziekenhuis Oost-Limburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Below the shoulder vascular anomaly
Above the shoulder vascular anomaly
Arm Description
If the standard J-tip guidewire does not cross a vascular anomaly located below the shoulder
If the standard J-tip guidewire does not cross a vascular anomaly located above the shoulder
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Change of access site
Is change of access site necessary?
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
Full Information
NCT ID
NCT05231889
First Posted
January 29, 2022
Last Updated
July 12, 2022
Sponsor
Ziekenhuis Oost-Limburg
1. Study Identification
Unique Protocol Identification Number
NCT05231889
Brief Title
Radifocus (Terumo) Versus Silverway (Asahi) to Deliver Catheters During Cardiac Catheterization
Acronym
RADVES
Official Title
Radifocus (Terumo) Versus Silverway (Asahi) to Deliver Catheters During Cardiac Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg
4. Oversight
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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anomalies Vascular
Keywords
Cardiac catheterization, Radifocus guide wire, Silverway guide wire
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Below the shoulder vascular anomaly
Arm Type
Placebo Comparator
Arm Description
If the standard J-tip guidewire does not cross a vascular anomaly located below the shoulder
Arm Title
Above the shoulder vascular anomaly
Arm Type
Active Comparator
Arm Description
If the standard J-tip guidewire does not cross a vascular anomaly located above the shoulder
Intervention Type
Device
Intervention Name(s)
Silverway guidewire
Intervention Description
The Silverway guidewire is a newly developed guidewire to overcome the problems the Radifocus guidewire has
Intervention Type
Device
Intervention Name(s)
Radifocus guidewire
Intervention Description
The Radifocus guidewire is a hydrophilic coated guidewire that is used when a standard J-tip guidewire does not cross a vascular anomaly
Primary Outcome Measure Information:
Title
Time in seconds from introduction to aortic root
Description
Measuring time from entering the guidewire in the catheter to delivery of the catheter to the aortic root (in seconds)
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
The ability of the study wire to deliver the catheter to the aortic root
Description
If the study wire is able to deliver the catheter to the aortic root
Time Frame
During procedure
Title
Change of access site
Description
Is change of access site necessary?
Time Frame
During procedure
Title
Interventional cardiologists' survey of grading parameters working with the guide wire
Description
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
Time Frame
Directly after procedure. Scale: not satisfactory (1) - somewhat satisfactory (2) - satisfactory (3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koen Ameloot, Dr.
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radifocus (Terumo) Versus Silverway (Asahi) to Deliver Catheters During Cardiac Catheterization
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