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Serpentine vs Traditional Hydrophilic Guidewire Tracking in Complex Radial Anatomy (S-TRACK)

15 de julio de 2026 actualizado por: Grigorios Tsigkas, University Hospital of Patras

Comparison of the "Serpentine" Technique Versus Hydrophilic Guidewire 0,035'' for Navigating Radial and Brachial Artery Loops, Tortuosity and Sharp Angulation During Transradial Access.

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.

Descripción general del estudio

Descripción detallada

Transradial access (TRA) has become the preferred approach for diagnostic coronary angiography and percutaneous coronary intervention (PCI), compared with transfemoral access (TFA). Contemporary guidelines on revascularization in both chronic and acute coronary syndromes (ACS) recommend TRA as the first-line strategy, primarily due to its reduced risk of complications.

Additional advantages of TRA include improved cost-effectiveness, shorter intensive care unit stay, shorter overall hospitalization, faster patient mobilization, and greater patient comfort. TRA has also been associated with reduced contrast use and a lower risk of contrast-induced acute kidney injury.

Despite its advantages, TRA has limitations. It is associated with a modest increase in radiation exposure. A key drawback is the need for crossover to another access site, which is relatively common; however, this can be mitigated by operator experience and ultrasound guidance.

Anatomical variants are a major cause of procedural failure and crossover, occurring in 9-23% of patients. The most frequent variants include high origin of the radial artery from the brachial artery, arterial loops, and tortuosity of the radial or subclavian artery. Radial artery loops and severe tortuosity, observed in 4.2-13,1% of cases, are strongly associated with procedural failure (3.8-50%) and increased crossover rates. These anatomical challenges prolong procedural time, increase radiation exposure, and raise the risk of vascular complication.

Several techniques have been proposed to overcome these challenges. The most commonly adopted is the use of hydrophilic guidewires. Other techniques include mechanical straightening of tortuous segments from the operator, the use of angioplasty guidewires, microcatheters, balloon-assisted tracking (BAT), pigtail-assisted tracking (PAT), or switching to ulnar, transfemoral, or contralateral radial access.

Preservation of the transradial approach is critical, as it reduces complications, facilitates faster mobilization, and shortens hospital stay. The most common cause of TRA failure is the presence of loops and tortuosity in the radial or brachial artery. To date, no randomized trials have directly compared different strategies for overcoming these challenges. The novel "Serpentine" technique, which will be compared against the widely used "0.035" hydrophilic guidewire, could become an additional tool for interventional cardiologists-providing a reliable method for crossing loops and tortuous segments, with reduced equipment use and comparable outcomes in terms of procedure time, radiation exposure, contrast use, and local complications.

The aim of this study is to compare the efficacy and safety of the novel "Serpentine" technique with that of hydrophilic guidewires in navigating radial and brachial artery loops and tortuosity during coronary angiography and PCI via TRA.

The S-TRACK Trial will be designed as a prospective, randomized, controlled, non-inferiority study. Consecutive eligible patients undergoing coronary angiography via transradial access, and not meeting any exclusion criteria, will be screened for enrollment. After successful radial artery cannulation, patients who demonstrate resistance to guidewire or catheter advancement will undergo radial and/or brachial angiography to identify the underlying anatomical cause. Participants with angiographically confirmed anatomical variants-specifically loops, pronounced tortuosity, or sharp angulations-will be considered eligible. Once the variant is confirmed, and oral consent provided, patients will be randomized in a 1:1 ratio to arterial navigation using either the standard hydrophilic 0.035'' guidewire-first technique or the Serpentine technique. At the end of the procedure informed consent will be signed. The study will involve operators-interventional cardiologists who will have been trained in the technique.

Baseline demographic, clinical, and laboratory parameters will be recorded, including age, sex, medical history, and indications for angiography. Additionally, the anatomical location of the loop or tortuosity will be recorded.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

204

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Grigorios Tsigkas, MD, PhD
  • Número de teléfono: +306974466662
  • Correo electrónico: gregtsig@hotmail.com

Ubicaciones de estudio

      • Pátrai, Grecia, 26504
        • Reclutamiento
        • University Hospital of Patras
        • Contacto:
          • Grigorios Tsigkas, MD, PhD
          • Número de teléfono: +306974466662
          • Correo electrónico: gregtsig@hotmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age ≥18 years
  • Feasibility of TRA
  • Indication for coronary angiography
  • Angiographic documentation of radial or brachial artery loop/tortuosity
  • Written informed consent

Exclusion Criteria:

  • STEMI - high risk NSTEMI presentation
  • Hemodynamic instability
  • Anatomical contraindications (e.g., arteriovenous fistula)
  • Significant calcification of the radial or brachial artery on angiographic evaluation.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Serpentine Technique
Participants will undergo transradial navigation of radial or brachial artery loops, tortuosity, or sharp angulation using the Serpentine catheter manipulation technique to facilitate coronary angiography or PCI.
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.
Comparador activo: Hydrophilic Technique
Participants will undergo transradial navigation of radial or brachial artery loops, tortuosity, or sharp angulation using a standard 0.035-inch hydrophilic guidewire to facilitate coronary angiography or PCI.
Navigation of radial or brachial artery loops, tortuosity, or sharp angulation using a 0.035-inch hydrophilic guidewire during transradial coronary angiography or PCI.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Successful crossing of anatomical obstacles and procedure completion
Periodo de tiempo: During coronary angiography/PCI procedure, assessed up to 3 hours
Successful crossing of radial/brachial artery loops or tortuosity with completion of coronary angiography or PCI.
During coronary angiography/PCI procedure, assessed up to 3 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total procedure time
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Total procedure time until completion of coronary angiography or PCI.
During index procedure, assessed up to 3 hours.
Fluoroscopy time
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Total fluoroscopy time measured during coronary angiography or PCI.
During index procedure, assessed up to 3 hours.
Radiation exposure
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Cumulative radiation dose assessed by Air Kerma and Dose Area Product (DAP) during the procedure.
During index procedure, assessed up to 3 hours.
Contrast volume used
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Total contrast medium volume used during coronary angiography or PCI.
During index procedure, assessed up to 3 hours.
Success rate of loop access per technique
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Successful navigation of radial or brachial artery loops or tortuosity using the assigned technique.
During index procedure, assessed up to 3 hours.
Number of guidewires used
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Total number of guidewires used during the procedure.
During index procedure, assessed up to 3 hours.
Number of catheters used
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Total number of catheters used during coronary angiography or PCI.
During index procedure, assessed up to 3 hours.
Radial artery spasm
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Occurrence of radial artery spasm during the procedure.
During index procedure, assessed up to 3 hours.
Procedure-related symptoms
Periodo de tiempo: During index procedure, assessed up to 3 hours.
Pain (VAS 0-10), paresthesia, or paresis occurring during the procedure.
During index procedure, assessed up to 3 hours.
Access-site vascular complications
Periodo de tiempo: From procedure completion until discharge, assessed up to 7 days
Occurrence of post-procedural hematoma (EASY scale), pseudoaneurysm, arterial dissection, or compartment syndrome.
From procedure completion until discharge, assessed up to 7 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Grigorios Tsigkas, MD, PhD, University Hospital of Patras

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de mayo de 2026

Finalización primaria (Estimado)

1 de mayo de 2029

Finalización del estudio (Estimado)

1 de noviembre de 2029

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de julio de 2026

Publicado por primera vez (Actual)

16 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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