Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention

February 8, 2021 updated by: China National Center for Cardiovascular Diseases
The objective of this study is to determine the rate of early radial artery occlusion following 7-French(7-Fr) transradial coronary intervention using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 7-Fr radial sheath.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Based on previously reported studies the rates of radial artery occlusion using a standard 7-Fr sheath is around 12%, compared to the previous studies of the Glidesheath Slender (see reference in the citations), the rate of radial artery occlusion was reported less than 5%. To prove Slender sheaths are superior to traditional ones, the sample size was estimated according to this, the class I error (α) is set as 0.05 on both sides, and the test efficiency (β) is set as 80%, then at least 248 patients are needed in each group.

This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion between the 7-Fr Glidesheath Slender (Terumo, Japan) and the standard 7-Fr radial sheath (cordis, USA) in patients undergoing complex transradial coronary intervention.

The study will enroll patients who will undergo elective complex percutaneous coronary intervention (PCI) via 7-Fr transradial approach at Fuwai Hospital National Center for Cardiovascular Diseases.

A baseline clinical vascular & ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.

Patients will be randomized in 1:1 fashion to either receive the 7-Fr Terumo Glidesheath Slender versus the currently used 7-Fr sheath.

The standard angiogram/ PCI will be performed as per usual practice. Following the PCI, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.

Study Type

Interventional

Enrollment (Anticipated)

500

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital National Center for Cardiovascular Diseases

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing coronary PCI via 7-Fr transradial approach
  • Informed consent
  • the patency of radial artery confirmed by ultrasound

Exclusion Criteria:

  • The abnormal of radial artery confirmed by ultrasound
  • Previous failed radial access.
  • Known bleeding disorder or hypercoagulable condition
  • Cardiogenic shock

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glidesheath Slender
The transradial procedure will be performed using the 7-Fr glidesheath slender (studied sheath)
Device: 7-Fr Glidesheath Slender
The 7 Fr Glidesheath Slender is a recently developed thin-walled radial sheath. It combines an ID of 2.46 mm, with an OD of 2.79 mm, representing thereby the thinnest 7 Fr sheath currently available on the market
Other Names:
  • Glidesheath Slender, Terumo, Tokyo, Japan
ACTIVE_COMPARATOR: Standard sheath
The transradial procedure will be performed using the standard 7- French radial sheath (comparator sheath)
Device: Cordis 7-Fr radial sheath
Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial artery occlusion
Time Frame: 24 hours
Evaluated clinically and by ultrasound
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular access site complications
Time Frame: 24 hours
Includes: bleeding or hematoma, pseudoaneurysm, artery dissection, arteriovenous fistula, compartment syndrome of the forearm
24 hours
Radial artery spasm
Time Frame: 24 hours
Radial artery spasm
24 hours
Procedure success
Time Frame: 24 hours
completion of the planned procedure through the initially selected radial access route
24 hours
The degree of pain at the puncture site
Time Frame: 24 hours
Scored on a scale of 1-10 scoring system
24 hours

Collaborators and Investigators

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

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Kefei Dou, MD,PhD, Fuwai Hospital National Center for Cardiovascular Diseases
  • Principal Investigator: Chenggang Zhu, MD,PhD, Fuwai Hospital National Center for Cardiovascular Diseases

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 (ANTICIPATED)

February 1, 2021

Primary Completion (ANTICIPATED)

May 31, 2021

Study Completion (ANTICIPATED)

May 31, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (ACTUAL)

February 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7F Glidesheath Slender

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

product manufactured in and exported from the U.S.

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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