Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients (DONATION)
Primary Purpose
Acute Coronary Syndrome, Procedural Complication
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
distal TRA group
conventional TRA group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Distal Radial Access, Radial Artery Occlusion, Major Adverse Cardiovascular Events
Eligibility Criteria
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
Sites / Locations
- Shenzhen People's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
dTRA group
TRA group
Arm Description
Investigators perform percutaneous coronary intervention by dTRA
Investigators perform percutaneous coronary intervention by conventional TRA
Outcomes
Primary Outcome Measures
Forearm radical occlusion
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
MACEs
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
Secondary Outcome Measures
Rate of One attempt success
Rate of One attempt success of 2 kinds of procedure
Access time
Access time of 2 kinds of procedure
Procedure time
Procedure time of 2 kinds of procedure
Crossover rate
Crossover rate of 2 kinds of procedure
Contrast dose
Contrast dose of 2 kinds of procedure
Fluoroscopy dose
Fluoroscopy dose of 2 kinds of procedure
hand hematoma
hand hematoma rate of 2 kinds of procedure
The total cost in hospitalization
Healthcare cost .
Full Information
NCT ID
NCT05255939
First Posted
January 17, 2022
Last Updated
February 24, 2022
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05255939
Brief Title
Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
Acronym
DONATION
Official Title
Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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, respectively. Investigators will also focus on puncture success in diagnostic and interventional cases, rate of One attempt success, access time, procedure time, crossover rate, contrast dose of patients, fluoroscopy time and dose, and healthcare cost of each group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Procedural Complication
Keywords
Distal Radial Access, Radial Artery Occlusion, Major Adverse Cardiovascular Events
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dTRA group
Arm Type
Experimental
Arm Description
Investigators perform percutaneous coronary intervention by dTRA
Arm Title
TRA group
Arm Type
Other
Arm Description
Investigators perform percutaneous coronary intervention by conventional TRA
Intervention Type
Procedure
Intervention Name(s)
distal TRA group
Intervention Description
dTRA for PCI procedure to ACS patients.
Intervention Type
Procedure
Intervention Name(s)
conventional TRA group
Intervention Description
Conventional TRA for PCI procedure to ACS patients
Primary Outcome Measure Information:
Title
Forearm radical occlusion
Description
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
Time Frame
during procedure
Title
MACEs
Description
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Rate of One attempt success
Description
Rate of One attempt success of 2 kinds of procedure
Time Frame
during procedure
Title
Access time
Description
Access time of 2 kinds of procedure
Time Frame
during procedure
Title
Procedure time
Description
Procedure time of 2 kinds of procedure
Time Frame
during procedure
Title
Crossover rate
Description
Crossover rate of 2 kinds of procedure
Time Frame
during procedure
Title
Contrast dose
Description
Contrast dose of 2 kinds of procedure
Time Frame
during procedure
Title
Fluoroscopy dose
Description
Fluoroscopy dose of 2 kinds of procedure
Time Frame
during procedure
Title
hand hematoma
Description
hand hematoma rate of 2 kinds of procedure
Time Frame
during procedure
Title
The total cost in hospitalization
Description
Healthcare cost .
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shenzhen People's hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tangzhiming Li, PhD.
Phone
+86 18588269277
Email
litangzhiming@126.com
First Name & Middle Initial & Last Name & Degree
Xin Sun, PhD.
Phone
+86 18126540853
Email
sunxinflying@163.com
First Name & Middle Initial & Last Name & Degree
Shaohong Dong, PhD.
12. IPD Sharing Statement
Plan to Share IPD
No
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Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
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