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

Not Applicable

• Conditions: Transradial; Intervention; Transulnar
• Interventions: Procedure: transulnar approach interventional procedure; Procedure: transradial approach interventional procedure

• Registration Number: NCT01979627
• Lead Sponsor: Fu Xianghua

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-03
• Study First Posted: 2013-11-08
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transulnar approach group	transulnar approach interventional procedure	Patients in transulnar group received interventional procedure through ulnar artery
transradial approach group	transradial approach interventional procedure	patients in transradial group received interventional procedure through radial artery

Primary Outcome Measures

Name	Time	Method
Coronary artery cannulation	1-12 month	vascular events including arterial occlusion through ulnar/radial artery approach

Secondary Outcome Measures

Name	Time	Method
Interventional procedure characteristic	during procedure	The secondary end points included the crossover rate, spasm, total time for the procedure
The access-site related complications	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

Trial Locations

Locations (1)

The second hospital of Hebei medical university; 🇨🇳 Shijiazhuang, Hebei, China