Anomalies VascularRADVESNCT05231889
Radifocus (Terumo) Versus Silverway (Asahi) to Deliver Catheters During Cardiac Catheterization
A study testing Silverway guidewire and Radifocus guidewire in people with Anomalies Vascular, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anomalies Vascular
- What is being tested?
- Silverway guidewire and Radifocus guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2022to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anomalies Vascular
- Being tested
- Silverway guidewire, Radifocus guidewire
- Keywords
- Cardiac catheterization, Radifocus guide wire, Silverway guide wire
- Medical subject headings
- Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silverway guidewireDevice
The Silverway guidewire is a newly developed guidewire to overcome the problems the Radifocus guidewire has
Radifocus guidewireDevice
The Radifocus guidewire is a hydrophilic coated guidewire that is used when a standard J-tip guidewire does not cross a vascular anomaly
| Study group | Role | What they receive |
|---|---|---|
| Below the shoulder vascular anomaly | Placebo comparator | If the standard J-tip guidewire does not cross a vascular anomaly located below the shoulder Receives: Device: Radifocus guidewire |
| Above the shoulder vascular anomaly | Active comparator | If the standard J-tip guidewire does not cross a vascular anomaly located above the shoulder Receives: Device: Silverway guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During procedure
Secondary outcomes (3)
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
Measured: During procedure
Change of access site
Is change of access site necessary?
Measured: 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
Measured: Directly after procedure. Scale: not satisfactory (1) - somewhat satisfactory (2) - satisfactory (3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start15 Feb 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomalies VascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Ameloot, Ziekenhuis Oost-Limburg
- Investigators
- Koen Ameloot, Dr., Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231889
- Sponsor's protocol ID
- Z-2021119
- Acronym
- RADVES
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radifocus (Terumo) Versus Silverway (Asahi) to Deliver Catheters During Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT05231889
- Acronym / sponsor ID
- RADVES / Z-2021119
- Conditions
- Anomalies Vascular
- Keywords
- Cardiac catheterization, Radifocus guide wire, Silverway guide wire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Below the shoulder vascular anomaly | Placebo comparator | Device: Radifocus guidewireIf the standard J-tip guidewire does not cross a vascular anomaly located below the shoulder |
| Above the shoulder vascular anomaly | Active comparator | Device: Silverway guidewireIf the standard J-tip guidewire does not cross a vascular anomaly located above the shoulder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silverway guidewireThe Silverway guidewire is a newly developed guidewire to overcome the problems the Radifocus guidewire has | Device | Above the shoulder vascular anomaly |
| Radifocus guidewireThe Radifocus guidewire is a hydrophilic coated guidewire that is used when a standard J-tip guidewire does not cross a vascular anomaly | Device | Below the shoulder vascular anomaly |
Primary outcome
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)
3 secondary outcomes
The ability of the study wire to deliver the catheter to the aortic root
Time frame: During procedure
Change of access site
Time frame: During procedure
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Ameloot, Dr. principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silverway guidewire and Radifocus guidewire in people with Anomalies Vascular, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in seconds from introduction to aortic root (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.