Safety and Efficacy of CAG and PCI Via Distal Transradial Access in Patients With Small Vessels

Official title

Safety and Efficacy of 6-French Glidesheath Slender in Coronary Angiography and Percutaneous Coronary Intervention Via Distal Transradial Access in Patients With Small Vessels: A Single-Center, Adaptive, Randomized Controlled Study

Overview

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.

Detailed description

The safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access (dTRA) have been confirmed by a large number of studies, but there are still few studies on its safety and efficacy in patients with small vessels (distal radial artery diameter \< 2.0mm). The 6-French Glidesheath Slender, with its smaller outer diameter, should be more suitable for patients with small vessels. To this end, we plan to conduct a single-center, adaptive, randomized controlled trial enrolling 594 patients aged 18-85 years old with distal radial artery diameters \<2.0 mm and ≥1.0 mm who are scheduled to undergo coronary angiography and percutaneous coronary intervention via the distal radial artery approach in our center. The study employed a stratification-block randomized design. Stratification was performed based on patient gender, with a block size of 4 within each stratum. Eligible patients were randomly assigned in a 1:1 ratio to either the 6-French Glidesheath Slender group or the 6-French conventional sheath group.

The primary endpoint of the study was distal radial artery occlusion assessed by vascular ultrasound 24 hours postoperatively. Secondary endpoints included puncture success rate, procedure success rate, number of punctures, puncture time, total procedural time, visual analogue scale pain scores during sheath placement, bleeding, hematoma, arteriovenous fistula, finger numbness, and conventional radial artery occlusion at 24 hours postoperatively.

An interim analysis will be conducted when 50% of the total sample size (297 patients) is enrolled, with subsequent sample size adjustments based on preliminary study results.

The results of this study will provide evidence for the safety and efficacy of 6-French Glidesheath Slender for coronary angiography and percutaneous coronary intervention in patients with small vessels via distal transradial access, and provide information for the selection of the best sheath equipment for patients with small vessels.

Interventions

• 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.
  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.
• 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.
  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.

Primary outcome measures

• Distal radial artery occlusion(dRAO) [Time frame: 24 hours postoperatively.]

Secondary outcome measures (11)

• Puncture success [Time frame: Periprocedural]
• Procedure success [Time frame: Periprocedural]
• Number of punctures [Time frame: Periprocedural]
• Puncture time(second) [Time frame: Periprocedural]
• Procedural time(minute) [Time frame: Periprocedural]
• Visual Analogue Scale (VAS) pain scores(0-10) during sheath placement [Time frame: Periprocedural]
• Bleeding [Time frame: 24 hours postoperatively]
• Haematoma [Time frame: 24 hours postoperatively]
• Arteriovenous fistula [Time frame: 24 hours postoperatively.]
• Finger numbness [Time frame: 24 hours postoperatively]
• Conventional radial artery occlusion (cRAO) [Time frame: 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 2 centers

• Changzhou Wujin People's Hospital — Changzhou
• Wujin Hospital Affiliated with Jiangsu University. — Changzhou

Publications

• 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. 2026 Jun;42(6):1221-1229. doi: 10.1016/j.cjca.2025.12.048. Epub 2025 Dec 30. PMID 41478549
• 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 30088362
• 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 33380922
• 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 34922888
• 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 38752401
• 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 39032557
• 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 37906607
• 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 38331793

Identifiers

NCT: NCT07410364 · 2025-SR-229

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗