Clinical trial NCT01979627: Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty
Official title: Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intervention
Transulnar
Transradial
Keywords: transulnar approach
transradial approach
angiography
angioplasty
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Coronary artery cannulation
timeFrame: 1-12 month
Secondary outcomes:
measure: Interventional procedure characteristic
timeFrame: during procedure
measure: The access-site related complications
timeFrame: 1-12 month follow up
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The second hospital of Hebei medical university
state: Hebei
Study officials:
References:
citation: Liu L, Xu XT, Yu Y, Sun Q, Yang Y, Qiu HB. Neural control of pressure support ventilation improved patient-ventilator synchrony in patients with different respiratory system mechanical properties: a prospective, crossover trial. Chin Med J (Engl). 2021 Jan 19;134(3):281-291. doi: 10.1097/CM9.0000000000001357.
citation: Bi X, Wang Q, Liu D, Gan Q, Liu L. Is the Complication Rate of Ulnar and Radial Approaches for Coronary Artery Intervention the Same? Angiology. 2017 Nov;68(10):919-925. doi: 10.1177/0003319717703226. Epub 2017 Apr 7.
citation: 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.