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

This study is currently recruiting participants.
Verified January 2017 by Fu Xianghua, The Second Hospital of Hebei Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979627
First Posted: November 8, 2013
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Fu Xianghua, The Second Hospital of Hebei Medical University
  Purpose
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.

Condition Intervention
Intervention Transulnar Transradial Procedure: transulnar approach interventional procedure Procedure: transradial approach interventional procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty

Resource links provided by NLM:


Further study details as provided by Fu Xianghua, The Second Hospital of Hebei Medical University:

Primary Outcome Measures:
  • Coronary artery cannulation [ Time Frame: 1-12 month ]
    vascular events including arterial occlusion through ulnar/radial artery approach


Secondary Outcome Measures:
  • Interventional procedure characteristic [ Time Frame: during procedure ]
    The secondary end points included the crossover rate, spasm, total time for the 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


Estimated Enrollment: 1000
Study Start Date: October 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transulnar approach group
Patients in transulnar group received interventional procedure through ulnar artery
Procedure: transulnar approach interventional procedure
transradial approach group
patients in transradial group received interventional procedure through radial artery
Procedure: transradial approach interventional procedure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979627


Contacts
Contact: Xianghua FU +8631166003803 fuxh999@163.com

Locations
China, Hebei
The second hospital of Hebei medical university Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Xianghua FU, doctor    +8631166003830    Fuxh999@163.com   
Principal Investigator: Xianghua FU, doctor         
Sponsors and Collaborators
Fu Xianghua
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fu Xianghua, director of cardiology department, The Second Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT01979627     History of Changes
Other Study ID Numbers: fuxhtransulnar
First Submitted: October 24, 2013
First Posted: November 8, 2013
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Fu Xianghua, The Second Hospital of Hebei Medical University:
transulnar approach
transradial approach
angiography
angioplasty