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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
October 24, 2013
November 8, 2013
January 11, 2017
October 2013
January 2017   (Final data collection date for primary outcome measure)
Coronary artery cannulation [ Time Frame: 1-12 month ]
vascular events including arterial occlusion through ulnar/radial artery approach
Coronary artery cannulation [ Time Frame: during procedure ]
Coronary artery cannulation is defined as guiding catheter was cannulated to ostia of coronary artery through ulnar/radial artery approach
Complete list of historical versions of study NCT01979627 on ClinicalTrials.gov Archive Site
  • 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
  • Interventional procedure characteristic [ Time Frame: during procedure ]
    The secondary end points included the number of needle punctures (from the first puncture to sheath insertion), time from first puncture to sheath insertion, total time for the procedure, total time under fluoroscopy, X-ray dose-area product (DAP)
  • The access-site related complications [ Time Frame: 30 days follow up ]
    The access-site related complications were defined as the occurrence of hematoma, artery stenosis, artery occlusion, arteriovenous fistula, pseudoaneurysm, and nerve injury
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Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty
Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Intervention
  • Transulnar
  • Transradial
  • Procedure: transulnar approach interventional procedure
  • Procedure: transradial approach interventional procedure
  • Experimental: transulnar approach group
    Patients in transulnar group received interventional procedure through ulnar artery
    Intervention: Procedure: transulnar approach interventional procedure
  • transradial approach group
    patients in transradial group received interventional procedure through radial artery
    Intervention: Procedure: transradial approach interventional procedure
Bi XL, Fu XH, Gu XS, Wang YB, Li W, Wei LY, Fan YM, Bai SR. Influence of Puncture Site on Radial Artery Occlusion After Transradial Coronary Intervention. Chin Med J (Engl). 2016 Apr 20;129(8):898-902. doi: 10.4103/0366-6999.179795.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
January 2017
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Xianghua FU +8631166003803 fuxh999@163.com
China
 
 
NCT01979627
fuxhtransulnar
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Not Provided
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Fu Xianghua, The Second Hospital of Hebei Medical University
Fu Xianghua
Not Provided
Not Provided
The Second Hospital of Hebei Medical University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP