NCT02831322

Brief Summary

Several approaches have been proposed to reduce the risk of RAO, including anticoagulation, immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal end rather than distal part of the artery,which was ignored by a majority of interventional cardiologists. Different insights into occlusion location may lead to different options of sheath materials, models, catheters and puncture access. Thus, the investigators designed this present study to explore the reason of radial artery endothelial dysfuction and damage and occlusion location by flow-mediated dilation (FMD) to determine the suitable method to reduce occlusion risk during TRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 4, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

July 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

July 4, 2016

Last Update Submit

February 14, 2023

Conditions

InterventionTransradial

Keywords

Transradialflow-mediated vasodilation

Outcome Measures

Primary Outcomes (1)

  • radial artery occlusion

    radial artery occlusion was the absence of a flow signal by Doppler ultrasound examination

    6 month

Study Arms (2)

radial artery occlusion

EXPERIMENTAL

Radial artery occlusion was the absence of a flow signal by Doppler ultrasound examination.

Procedure: Percutaneous coronary intervention

radial artery normal

OTHER

Radial artery normal was blood flow signal by Doppler ultrasound

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionPROCEDURE

Percutaneous coronary intervention was a nonsurgical technique for treating obstructive coronary artery disease

radial artery normalradial artery occlusion

Eligibility Criteria

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

You may qualify if:

  • admitted for transradial catheterization.

You may not qualify if:

  • femoral access, arterial circulatory disease, pathological Allen tests, decompensated heart failure, chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingsheng wang

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 13, 2016

Study Start

July 10, 2016

Primary Completion

September 5, 2016

Study Completion

October 1, 2017

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)