NCT01979627

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

October 24, 2013

Last Update Submit

January 9, 2017

Conditions

InterventionTransulnarTransradial

Keywords

transulnar approachtransradial approachangiographyangioplasty

Outcome Measures

Primary Outcomes (1)

  • Coronary artery cannulation

    vascular events including arterial occlusion through ulnar/radial artery approach

    1-12 month

Secondary Outcomes (2)

  • Interventional procedure characteristic

    during procedure

  • The access-site related complications

    1-12 month follow up

Study Arms (2)

transulnar approach group

EXPERIMENTAL

Patients in transulnar group received interventional procedure through ulnar artery

Procedure: transulnar approach interventional procedure

transradial approach group

OTHER

patients in transradial group received interventional procedure through radial artery

Procedure: transradial approach interventional procedure

Interventions

transulnar approach interventional procedurePROCEDURE
transulnar approach group
transradial approach interventional procedurePROCEDURE
transradial approach group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of coronary artery disease
  • Needed to perform coronary angiography or angioplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second hospital of Hebei medical university

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (4)

  • Chen J, Huai J, Lin L, Li B, Zhu Y, Yang H. Low-dose aspirin in the prevention of pre-eclampsia in China: postpartum hemorrhage in subgroups of women according to their characteristics and potential bleeding risk. Chin Med J (Engl). 2023 Mar 5;136(5):550-555. doi: 10.1097/CM9.0000000000002545.

    PMID: 36914957DERIVED

  • 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.

    PMID: 33470654DERIVED

  • 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.

    PMID: 28387125DERIVED

  • 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.

    PMID: 27064032DERIVED

Central Study Contacts

Xianghua FU

CONTACT

+8631166003803fuxh999@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of cardiology department

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 8, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

CN(1)