Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty

January 9, 2017 updated by: Fu Xianghua
The transradial approach for coronary angiography and angioplasty is now widely used in catheterization laboratories worldwide, which had been shown as advantages over the conventional femoral and brachial approaches due to the lower incidence of bleeding and other cardiovascular complications. However, the transradial approach does not seem suitable for 5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery which is one of the two terminal branches of the brachial artery is usually larger than radial artery and it may be as a potential approach for cardiac catheterization. Recently, some reports have demonstrated that the transulnar approach may be both feasible and safe for coronary angiography and angioplasty in selective patients.we performed this study to evaluate the safety and feasibility of transulnar approach coronary catheterization in real world non-selective patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

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
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
        • Principal Investigator:
          • Xianghua FU, doctor

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of coronary artery disease
  • Needed to perform coronary angiography or angioplasty

Exclusion Criteria:

  • Arterial circulatory disease in an upper limb
  • History of deformity
  • Forearm trauma
  • Forearm amputated
  • Hemodialysis
  • Symptomatic peripheral artery disease
  • Raynaud's syndrome
  • Hemorrhagic disease
  • Cardiogenic shock
  • Others who were unwilling to participate the study

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transulnar approach group
Patients in transulnar group received interventional procedure through ulnar artery
Procedure: transulnar approach interventional procedure
Other: transradial approach group
patients in transradial group received interventional procedure through radial artery
Procedure: transradial approach interventional procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary artery cannulation
Time Frame: 1-12 month
vascular events including arterial occlusion through ulnar/radial artery approach
1-12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interventional procedure characteristic
Time Frame: during procedure
The secondary end points included the crossover rate, spasm, total time for the procedure
during procedure
The access-site related complications
Time Frame: 1-12 month follow up
The access-site related complications were defined as the occurrence of hematoma, artery stenosis, arteriovenous fistula, pseudoaneurysm, and nerve injury
1-12 month follow up

Collaborators and Investigators

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

Sponsor

Fu Xianghua

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

October 1, 2013

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

November 3, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • fuxhtransulnar

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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