Ziekenhuis Oost-Limburg
Genk, Limburg, 3600, Belgium
NCT Number: NCT05231889
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Genk, Limburg, 3600, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Silverway guidewire is a newly developed guidewire to overcome the problems the Radifocus guidewire has
The Radifocus guidewire is a hydrophilic coated guidewire that is used when a standard J-tip guidewire does not cross a vascular anomaly
Time frame: During procedure
Measuring time from entering the guidewire in the catheter to delivery of the catheter to the aortic root (in seconds)
Time frame: During procedure
If the study wire is able to deliver the catheter to the aortic root
Time frame: During procedure
Is change of access site necessary?
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
Ziekenhuis Oost-Limburg
Other
Acronym: RADVES
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.
NCT07728825
Cardiovascular Abnormalities, Cardiovascular Diseases
Fallujah, Al-Anbar Governorate, Iraq
View Trial DetailsNCT06986954
Aneurysm, False, Bleed Intracranial
Darien, Connecticut, United States
View Trial DetailsNCT05563831
Angiomatosis, CLOVES Syndrome
Paris, France
View Trial DetailsNCT03972592
Cardiovascular Abnormalities, Cardiovascular Diseases
Angers, France
View Trial Details