NCT07707427

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
May 2026Nov 2029

Study Start

First participant enrolled

May 14, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 6, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

Coronary catheterizationTransradial access(TRA)Coronary Angiography (CAG)Percutaneous Coronary Intervention (PCI)Radial artery loopRadial artery tortuositySerpentine TechniqueHydrophilic GuidewireComplex Radial AnatomyVascular Complications

Outcome Measures

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.

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

Secondary Outcomes (10)

  • Total procedure time

    During index procedure, assessed up to 3 hours.

  • Fluoroscopy time

    During index procedure, assessed up to 3 hours.

  • Radiation exposure

    During index procedure, assessed up to 3 hours.

  • Contrast volume used

    During index procedure, assessed up to 3 hours.

  • Success rate of loop access per technique

    During index procedure, assessed up to 3 hours.

  • +5 more secondary outcomes

Study Arms (2)

Serpentine Technique

EXPERIMENTAL

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.

Procedure: Serpentine Technique

Hydrophilic Technique

ACTIVE COMPARATOR

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.

Procedure: Hydrophilic Technique

Interventions

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.

Serpentine Technique

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

Hydrophilic Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

PĂ¡trai, 26504, Greece

RECRUITING

Related Publications (40)

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Study Officials

  • Grigorios Tsigkas, MD, PhD

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grigorios Tsigkas, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tsigkas Grigorios pHD,Assistant proffessor of Cardiology at University Hospital of Patras

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 16, 2026

Study Start

May 14, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations