Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

15. července 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

204

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

      • Pátrai, Řecko, 26504
        • Nábor
        • University Hospital of Patras
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Successful crossing of anatomical obstacles and procedure completion
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total procedure time
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Grigorios Tsigkas, MD, PhD, University Hospital of Patras

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

14. května 2026

Primární dokončení (Odhadovaný)

1. května 2029

Dokončení studie (Odhadovaný)

1. listopadu 2029

Termíny zápisu do studia

První předloženo

6. července 2026

První předloženo, které splnilo kritéria kontroly kvality

15. července 2026

První zveřejněno (Aktuální)

16. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit