- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05230719
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
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
- Name: Tangzhiming Li, PhD.
- Phone Number: +86 18588269277
- Email: litangzhiming@126.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518000
- Recruiting
- ShenZhen People's Hospital
-
Contact:
- Tangzhiming Li, PhD.
- Phone Number: +86 18588269277
- Email: litangzhiming@126.com
-
Contact:
- Xin Sun, PhD.
- Phone Number: +86 18126540853
- Email: sunxinflying@163.com
-
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
|
dTRA or conventional TRA for radical artery approach
|
TRA group
Investigators perform percutaneous coronary intervention by conventional TRA for patients
|
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
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
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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