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

15 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

204

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Pátrai, Grecia, 26504
        • Reclutamento
        • University Hospital of Patras
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Successful crossing of anatomical obstacles and procedure completion
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total procedure time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Grigorios Tsigkas, MD, PhD, University Hospital of Patras

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 maggio 2026

Completamento primario (Stimato)

1 maggio 2029

Completamento dello studio (Stimato)

1 novembre 2029

Date di iscrizione allo studio

Primo inviato

6 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 luglio 2026

Primo Inserito (Effettivo)

16 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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