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

2026년 7월 15일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

204

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Pátrai, 그리스, 26504
        • 모병
        • University Hospital of Patras
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Successful crossing of anatomical obstacles and procedure completion
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Total procedure time
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Grigorios Tsigkas, MD, PhD, University Hospital of Patras

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 14일

기본 완료 (추정된)

2029년 5월 1일

연구 완료 (추정된)

2029년 11월 1일

연구 등록 날짜

최초 제출

2026년 7월 6일

QC 기준을 충족하는 최초 제출

2026년 7월 15일

처음 게시됨 (실제)

2026년 7월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 15일

마지막으로 확인됨

2026년 7월 1일

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