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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01979627
Other study ID # fuxhtransulnar
Secondary ID
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

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
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