Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study (DONATION-OB)

February 11, 2022 updated by: Shenzhen People's Hospital
The site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. Transradial access (TRA) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (RAO) that limits the radial artery for future needs. Distal radial access (dTRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dTRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort. This study aims to reveal the feasibility and safety of dTRA and routine TRA procedures in acute coronary syndrome patients. The primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (MACEs) in the two groups. Investigators conduct this retrospected analysis to demonstrate the difference of the two procedure of Cannulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shaohong Dong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients who received coronary angiography, based on arterial cannulation procedure, were divided into two groups, dTRA and conventional TRA. We conduct this study to illustrate the complication and MACEs of these two kinds of access.

Description

Inclusion Criteria:

  • presence of a pulse in the snuffbox

Exclusion Criteria:

  • Absence of pulse
  • Ultrasound indication of arterial occlusion or severe calcification
  • Severe forearm artery malformation
  • Patients with severe liver and renal failure, or abnormal coagulation function
  • Established cardiogenic shock
  • History of previous coronary artery bypass grafting and radial artery use.
  • Raynaud's disease in the medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dTRA group
Investigators perform percutaneous coronary intervention by dTRA for patients
Procedure: Radial Artery Approach
dTRA or conventional TRA for radical artery approach
TRA group
Investigators perform percutaneous coronary intervention by conventional TRA for patients
Procedure: Radial Artery Approach
dTRA or conventional TRA for radical artery approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forearm radical
Time Frame: 2 years
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
2 years
MACEs
Time Frame: 2 years
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 29, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DONATION-OB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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