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

Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979627
• Other study ID #: fuxhtransulnar
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2013
• Last updated: January 9, 2017
• Start date: October 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: The Second Hospital of Hebei Medical University
• Contact: Xianghua FU
• Phone: +8631166003803
• Email: fuxh999[@]163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervention
• Transradial
• Transulnar

Intervention

Procedure:
• transulnar approach interventional procedure

• transradial approach interventional procedure

Locations

Country	Name	City	State
China	The second hospital of Hebei medical university	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Fu Xianghua

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary artery cannulation	vascular events including arterial occlusion through ulnar/radial artery approach	1-12 month	No
Secondary	Interventional procedure characteristic	The secondary end points included the crossover rate, spasm, total time for the procedure	during procedure	No
Secondary	The access-site related complications	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	No