GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART) (SMART)

December 18, 2023 updated by: Wujin People's Hospital

GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Incidence of Distal Radial Artery Occlusion in Cardiovascular Intervention Via Distal Radial Artery (SMART)

Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath Slender® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath Slender® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Distal transradial artery (dTRA) approach has emerged as a new approach in cardiovascular intervention in recent years. Compared to the conventional radial artery (CRA) approach, the dTRA approach dramatically reduced the risk of radial artery occlusion (RAO). In recent years, the incidence of distal radial artery occlusion (dRAO) after dTRA intervention has been reported in the literature, ranged from 0.12% to 5.2%. Outside diameter of artery sheath may affect the incidence of dRAO. Retrospective study reported that an artery/ sheath ratio > 1.0 was least damaging to the vessel during coronary intervention via dTRA. Compared with conventional artery sheath (TERUMO, Introducer II ), 6 French GlideSheath Slender® has more smaller outer-side diameter (2.46mm vs. 2.62mm). The investigators suspected that use of the GlideSheath Slender can reduce the incidence of dRAO in cardiovascular intervention via dTRA approach.

Study Type

Interventional

Enrollment (Estimated)

600

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

  • Name: Gaojun Cai, Dr.
  • Phone Number: 086-0519-85579193
  • Email: cgj982@126.com

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

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

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Palpable distal radial and conventional radial artery

Exclusion Criteria:

  • Age ≥ 90years
  • Height≥ 185cm
  • ST-segment elevation myocardial infarction or Cardiogenic shock
  • Contraindications to puncture at the puncture site
  • Diameter of DRA less than 1.5mm or RAO

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GlideSheath Slender®
Placement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery
Device: GlideSheath Slender® and conventional arterial sheath
Using the GlideSheath Slender® with the outside diameter 2.46mm
Active Comparator: Conventional Sheath
Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery
Device: Conventional arterial sheath
Placement of 6 French conventional Sheath (TERUMO, Introducer II )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of distal radial artery occlusion
Time Frame: 24 hours after the coronary angiography or intervention
The rate of distal radial artery occlusion is evaluated by ultrasound
24 hours after the coronary angiography or intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of radial artery occlusion
Time Frame: 24 hours after the coronary angiography or intervention
The rate of radial artery occlusion is evaluated by ultrasound
24 hours after the coronary angiography or intervention
Pain during the placement of the sheath
Time Frame: 24 hours after the coronary angiography or intervention
Visual analog scale is used to evaluate the pain during the placement of the sheath, which ranges from 0-10, and 0 meas no pain
24 hours after the coronary angiography or intervention
Radial artery dissection
Time Frame: 24 hours after the coronary angiography or intervention
The incidence of dissection of the radial artery is evaluated by ultrasound
24 hours after the coronary angiography or intervention
Time of hemostasis
Time Frame: 24 hours after the coronary angiography or intervention
The time from the compress to hemostasis
24 hours after the coronary angiography or intervention
Haematoma
Time Frame: 24 hours after the coronary angiography or intervention
The incidence of haematoma is evaluated by Early Discharge After Transradial Stenting of Coronary Arteries Study criteria
24 hours after the coronary angiography or intervention

Collaborators and Investigators

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

Sponsor

Wujin People's Hospital

Investigators

  • Study Chair: Gaojun Cai, 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

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)

September 15, 2022

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

August 6, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJH20220731

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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