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Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access

NCT06585917 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2025-02-25

No results posted yet for this study

Summary

This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. The study population includes adult patients who are candidates for coronary intervention. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure.

Conditions

  • PCI
  • Coronary Arterial Disease (CAD)

Interventions

DEVICE

7F Thin-Walled Sheath

The 7F Thin-Walled Sheath is used during coronary intervention procedures via distal radial artery access. This device has a smaller outer diameter compared to traditional 7F sheaths, designed to reduce the risk of vascular complications while allowing for the performance of complex coronary interventions.

DEVICE

6F Thin-Walled Sheath

The 6F Thin-Walled Sheath is the standard device used in coronary intervention procedures via distal radial artery access. It is employed as a control in this study to compare its efficacy and safety against the 7F Thin-Walled Sheath.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Lijian Gao, PhD. MD. · Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2025-09-30
Completion
2026-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06585917 on ClinicalTrials.gov