NCT07410364

Brief Summary

Randomized controlled trial of adaptive design for the safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access using a 6-French Glidesheath Slender in patients with small vessels.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
594

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
21mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

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 Progress12%
Feb 2026Feb 2028

First Submitted

Initial submission to the registry

January 21, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 24, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 19, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 21, 2026

Last Update Submit

May 18, 2026

Conditions

Coronary Artery Disease

Keywords

Distal radial arterySmall vesselUltrasoundDistal radial artery occlusionRadial artery occlusionVisual analog scaleSafetyEfficacy

Outcome Measures

Primary Outcomes (1)

  • Distal radial artery occlusion(dRAO)

    The dRAO is defined as the absence of blood flow in the distal radial artery assessed by the doppler ultrasound.

    24 hours postoperatively.

Secondary Outcomes (11)

  • Puncture success

    Periprocedural

  • Procedure success

    Periprocedural

  • Number of punctures

    Periprocedural

  • Puncture time(second)

    Periprocedural

  • Procedural time(minute)

    Periprocedural

  • +6 more secondary outcomes

Study Arms (2)

6-French Glidesheath Slender group

EXPERIMENTAL

Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-French Glidesheath Slender sheath.

Device: Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath.

6-F Conventional sheath group

SHAM COMPARATOR

Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-F Conventional sheath.

Device: Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.

Interventions

Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.DEVICE

Coronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA \< 2.0 mm) via the distal transradial access using a 6-French Conventional sheath.

Also known as: 6-Fr Conventional sheath
6-F Conventional sheath group
Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath.DEVICE

Coronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA \< 2.0 mm) via the distal transradial access using a 6-French Glidesheath Slender sheath.

Also known as: 6-French Glidesheath Slender
6-French Glidesheath Slender group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 85 years
  • Palpable pulses in both the distal radial artery and conventional radial artery
  • All patients signed informed consent forms prior to procedure

You may not qualify if:

  • Ultrasound assessment of the distal radial artery diameter ≥2.0mm or \<1.0mm
  • Height ≥185.0cm
  • Patients with acute ST-segment elevation myocardial infarction, cardiogenic shock, or hemodynamic instability
  • Contraindications for puncture of the distal radial artery
  • Patients with Raynaud's syndrome
  • Patients with coagulation disorders or hematologic diseases
  • Patients currently enrolled in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Changzhou Wujin People's Hospital

Changzhou, Jiangsu, 213017, China

RECRUITING

Wujin Hospital Affiliated with Jiangsu University.

Changzhou, Jiangsu, 213017, China

RECRUITING

Related Publications (8)

  • Li F, Zhou T, Fan X, Chen T, Shi G, Li L, Cai G. Safety and Efficacy of Distal Transradial Access in Patients With Small Diameter Distal Radial Artery: A Post Hoc Analysis of 2 Randomized Trials. Can J Cardiol. 2025 Dec 30:S0828-282X(25)01616-2. doi: 10.1016/j.cjca.2025.12.048. Online ahead of print.

    PMID: 41478549RESULT

  • Kim Y, Ahn Y, Kim I, Lee DH, Kim MC, Sim DS, Hong YJ, Kim JH, Jeong MH. Feasibility of Coronary Angiography and Percutaneous Coronary Intervention via Left Snuffbox Approach. Korean Circ J. 2018 Dec;48(12):1120-1130. doi: 10.4070/kcj.2018.0181. Epub 2018 Aug 6.

    PMID: 30088362RESULT

  • Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.

    PMID: 33380922RESULT

  • Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.

    PMID: 34922888RESULT

  • Chen T, Huang H, Li L, Yang A, Shi G, Li F, Lu W, Xu L, Cai G. Analysis of the diameter of the distal radial artery at anatomic snuffbox by ultrasonography in patients scheduled for coronary intervention. J Vasc Access. 2025 May;26(3):896-903. doi: 10.1177/11297298241250263. Epub 2024 May 16.

    PMID: 38752401RESULT

  • Lu W, Chen T, Wang H, Yang A, Li L, Shi G, Xue S, Li F, Xiao J, Gu J, Zhang L, Liang X, Li W, Cai G. Comparison of the Effect of a 6-French Glidesheath Slender and a Conventional Sheath on Distal Radial Artery Occlusion: A Randomized Controlled Trial. Can J Cardiol. 2024 Nov;40(11):2292-2300. doi: 10.1016/j.cjca.2024.07.011. Epub 2024 Jul 19.

    PMID: 39032557RESULT

  • Chen T, Li L, Yang A, Huang H, Shi G, Li F, Li W, Lu W, Xu L, Li L, Cai G. Incidence of Distal Radial Artery Occlusion and its Influencing Factors After Cardiovascular Intervention Via the Distal Transradial Access. J Endovasc Ther. 2025 Oct;32(5):1408-1416. doi: 10.1177/15266028231208638. Epub 2023 Oct 31.

    PMID: 37906607RESULT

  • Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7.

    PMID: 38331793RESULT

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseArterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisVascular Diseases

Study Officials

  • haiyan HY zhang, BS

    Wujin Hospital Affiliated with Jiangsu University.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

gaojun GJ cai, PhD

CONTACT

+86 0519-85579192caigaojun@wjrmyy.cn

feng F li, MD

CONTACT

+86 85579192lifeng@wjrmyy.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Because cardiac interventionalists need to know which arterial sheaths to use during the procedure, therefore it is not possible to blind them to this information. But, the investigators responsible for outcome assessment and the personnel responsible for preoperative and postoperative radial artery ultrasound evaluations will be blind of this.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Head of Departments of Cardiology, Clinical Professor.

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 13, 2026

Study Start

February 24, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

May 19, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)