Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

April 8, 2021 updated by: Yujie Zhou, Beijing Anzhen Hospital

Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.

It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.

Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

938

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: Lixia Yang, Doctor
  • Phone Number: 13661339066
  • Email: ylx966@163.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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is over 18 years of age.
  • Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
  • Patient has provided written informed consent.
  • Patient is willing to comply with all protocol-required evaluations during the hospitalization.

Exclusion Criteria:

  • No palpable radial artery or distal radial artery.
  • Radial artery used as a bridging vessel.
  • Severe heart failure (NYHA class IV).
  • Severe renal insufficiency ( SCr>443umol/L).
  • Height over 185 cm.
  • A ≥7F catheter may be required for operation.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dTRA group
Procedure: Coronary Angiography and Intervention
Transradial access puncture site
Active Comparator: cTRA group
Procedure: Coronary Angiography and Intervention
Transradial access puncture site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial artery occlusion
Time Frame: Within 24 hours after the procedure.
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.
Within 24 hours after the procedure.

Collaborators and Investigators

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

Sponsor

Beijing Anzhen Hospital

Investigators

  • Study Chair: Yujie Zhou, Doctor, Beijing Anzhen Hospital

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)

April 10, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC radial

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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