Acute Coronary SyndromeDONATIONNCT05255939
Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
A study testing distal TRA group and conventional TRA group in people with Acute Coronary Syndrome and Procedural Complication, run by Shenzhen People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, Procedural Complication
- What is being tested?
- distal TRA group and conventional TRA group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of a pulse in the snuffbox
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen People's hospital
Shenzhen, Guangdong, 518000
Tangzhiming Li, PhD., +86 18588269277, litangzhiming@126.com
Xin Sun, PhD., +86 18126540853, sunxinflying@163.com
About this study
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.
- Conditions
- Acute Coronary Syndrome, Procedural Complication
- Being tested
- distal TRA group, conventional TRA group
- Keywords
- Distal Radial Access, Radial Artery Occlusion, Major Adverse Cardiovascular Events
- Medical subject headings
- Acute Coronary Syndrome, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal TRA groupProcedure or surgery
dTRA for PCI procedure to ACS patients.
conventional TRA groupProcedure or surgery
Conventional TRA for PCI procedure to ACS patients
| Study group | Role | What they receive |
|---|---|---|
| dTRA group | Experimental | Investigators perform percutaneous coronary intervention by dTRA Receives: Procedure: distal TRA group |
| TRA group | Other | Investigators perform percutaneous coronary intervention by conventional TRA Receives: Procedure: conventional TRA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm radical occlusion
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
Measured: during procedure
MACEs
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
Measured: during procedure
Secondary outcomes (8)
Rate of One attempt success
Rate of One attempt success of 2 kinds of procedure
Measured: during procedure
Access time
Access time of 2 kinds of procedure
Measured: during procedure
Procedure time
Procedure time of 2 kinds of procedure
Measured: during procedure
Crossover rate
Crossover rate of 2 kinds of procedure
Measured: during procedure
Contrast dose
Contrast dose of 2 kinds of procedure
Measured: during procedure
Fluoroscopy dose
Fluoroscopy dose of 2 kinds of procedure
Measured: during procedure
hand hematoma
hand hematoma rate of 2 kinds of procedure
Measured: during procedure
The total cost in hospitalization
Healthcare cost .
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255939
- Sponsor's protocol ID
- DONATION
- Acronym
- DONATION
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
- ClinicalTrials.gov ID
- NCT05255939
- Acronym / sponsor ID
- DONATION / DONATION
- Conditions
- Acute Coronary Syndrome, Procedural Complication
- Keywords
- Distal Radial Access, Radial Artery Occlusion, Major Adverse Cardiovascular Events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dTRA group | Experimental | Procedure: distal TRA groupInvestigators perform percutaneous coronary intervention by dTRA |
| TRA group | Other | Procedure: conventional TRA groupInvestigators perform percutaneous coronary intervention by conventional TRA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presence of a pulse in the snuffbox
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distal TRA groupdTRA for PCI procedure to ACS patients. | Procedure or surgery | dTRA group |
| conventional TRA groupConventional TRA for PCI procedure to ACS patients | Procedure or surgery | TRA group |
Primary outcome
Forearm radical occlusion
Time frame: during procedure
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
MACEs
Time frame: during procedure
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
8 secondary outcomes
Rate of One attempt success
Time frame: during procedure
Access time
Time frame: during procedure
Procedure time
Time frame: during procedure
Crossover rate
Time frame: during procedure
Contrast dose
Time frame: during procedure
Fluoroscopy dose
Time frame: during procedure
hand hematoma
Time frame: during procedure
The total cost in hospitalization
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distal TRA group and conventional TRA group in people with Acute Coronary Syndrome and Procedural Complication, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm radical occlusion (time frame: during procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.