Serpentine vs Traditional Hydrophilic Guidewire Tracking in Complex Radial Anatomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of Patras

About this trial

Coronary angiography and angioplasty are commonly performed through the radial artery. In some patients, anatomical variations of the radial and brachial arteries, such as loops, increased tortuosity or sharp angulations may pose challenges to equipment advancement.

Both the hydrophilic guidewire 0,035'' approach and the "Serpentine" technique have been described in the literature as techniques for overcoming radial anatomical challenges, with the hydrophilic guidewire approach being the more commonly used method.

In practical terms, both techniques involve the use of the same standard materials, with differences relating mainly to operator handling and technical manipulation. This study does not introduce any experimental device, material, or treatment; instead, it aims to compare the established approach using a 0.035'' hydrophilic guidewire with the emerging " Serpentine" technique with respect to effectiveness, procedural time, and safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Feasibility of TRA

Indication for coronary angiography

Angiographic documentation of radial or brachial artery loop/tortuosity

Disqualifiers

STEMI - high risk NSTEMI presentation

Hemodynamic instability

Anatomical contraindications (e.g., arteriovenous fistula)

Significant calcification of the radial or brachial artery on angiographic evaluation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serpentine Technique

    Procedure/Surgery

    Catheter-based navigation technique using controlled rotational catheter manipulation to cross radial or brachial artery loops, tortuosity, or sharp angulation during transradial coronary angiography or PCI.

  • Hydrophilic Technique

    Procedure/Surgery

    Navigation of radial or brachial artery loops, tortuosity, or sharp angulation using a 0.035-inch hydrophilic guidewire during transradial coronary angiography or PCI.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Serpentine TechniqueExperimental treatment 1 intervention
Group B: Hydrophilic TechniqueActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Successful crossing of anatomical obstacles and procedure completion

Successful crossing of radial/brachial artery loops or tortuosity with completion of coronary angiography or PCI.

Time frame
During coronary angiography/PCI procedure, assessed up to 3 hours

Secondary outcomes

1

Total procedure time

Total procedure time until completion of coronary angiography or PCI.

Time frame
During index procedure, assessed up to 3 hours.
2

Fluoroscopy time

Total fluoroscopy time measured during coronary angiography or PCI.

Time frame
During index procedure, assessed up to 3 hours.
3

Radiation exposure

Cumulative radiation dose assessed by Air Kerma and Dose Area Product (DAP) during the procedure.

Time frame
During index procedure, assessed up to 3 hours.
4

Contrast volume used

Total contrast medium volume used during coronary angiography or PCI.

Time frame
During index procedure, assessed up to 3 hours.

Other outcomes

Sponsors and contacts

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