Safety and Efficacy of CAG and PCI Via Distal Transradial Access in Patients With Small Vessels (DISTAL-SV)

May 18, 2026 updated by: Cai gaojun, MD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

594

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213017
        • Recruiting
        • Changzhou Wujin People's Hospital
        • Contact:
          • Gaojun Cai, MD
          • Phone Number: +86-0519-85579193
          • Email: cgj982@126.com
      • Changzhou, Jiangsu, China, 213017
        • Recruiting
        • Wujin Hospital Affiliated with Jiangsu University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6-French Glidesheath Slender group
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.
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.
Other Names:
  • 6-French Glidesheath Slender
Sham Comparator: 6-F Conventional sheath group
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.
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.
Other Names:
  • 6-Fr Conventional sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distal radial artery occlusion(dRAO)
Time Frame: 24 hours postoperatively.
The dRAO is defined as the absence of blood flow in the distal radial artery assessed by the doppler ultrasound.
24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Puncture success
Time Frame: Periprocedural
Puncture success is defined as complete insertion of the artery sheath.
Periprocedural
Procedure success
Time Frame: Periprocedural
Procedure success is defined as the whole procedure was completed from the same access.
Periprocedural
Number of punctures
Time Frame: Periprocedural
The number of punctures is defined as the number of attempts made before a successful puncture.
Periprocedural
Puncture time(second)
Time Frame: Periprocedural
Puncture time is defined as the time from the end of local anaesthesia to the sheath completely implanted into the vessel.
Periprocedural
Procedural time(minute)
Time Frame: Periprocedural
Procedural time is defined as the time from the initiation of the puncture to the completion of the procedure.
Periprocedural
Visual Analogue Scale (VAS) pain scores(0-10) during sheath placement
Time Frame: Periprocedural
With a 10-cm straight line divided into 10 equal parts to rate pain with 0 indicating no pain and 10 for extreme pain.
Periprocedural
Bleeding
Time Frame: 24 hours postoperatively
Bleeding events are defined according to the BARC criteria.
24 hours postoperatively
Haematoma
Time Frame: 24 hours postoperatively
Haematoma was assessed according to the mEASY( A modified version of the Early Discharge After Transradial Stenting of Coronary Arteries Study) classification.
24 hours postoperatively
Arteriovenous fistula
Time Frame: 24 hours postoperatively.
Number of participants with the arteriovenous fistula is assessed by the doppler ultrasound 24 hours postoperatively.
24 hours postoperatively.
Finger numbness
Time Frame: 24 hours postoperatively
Number of participants with the finger numbness 24 hours postoperatively.
24 hours postoperatively
Conventional radial artery occlusion (cRAO)
Time Frame: 24 hours postoperatively
The cRAO is defined as the absence of blood flow in the conventional radial artery assessed by the doppler ultrasound.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cai gaojun, MD

Investigators

  • Principal Investigator: haiyan HY zhang, BS, Wujin Hospital Affiliated with Jiangsu University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-SR-229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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