ST Segment Elevation Myocardial InfarctionRAPIDIIINCT05461781
Distal Radial Access for Primary PCI in STEMI Patients to Prevent RAO
A study testing distal radial access and conventional transradial access in people with ST Segment Elevation Myocardial Infarction, run by Beijing Luhe Hospital at 1 site in China.
Trial summary
Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction
- What is being tested?
- distal radial access and conventional transradial access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 30 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- ST-segment elevation myocardial infarction for primary percuteous coronary intervention
- Palpable pulses on both access sites of the radial artery
- Informed consent
Who cannot join
- Thrombolysis before primary percutaneous coronary intervention
- Previous CABG or radio-cephalic fistula using radial artery
- Cardiogenic shock
- Severe arrhythmias
- Severe liver and kidney dysfunction
- Pregnancy
- Enrolment in another study within 1 month
- Inability to obtain written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distal Radial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion
Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.
Read the detailed description
Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.
- Being tested
- distal radial access, conventional transradial access
- Keywords
- radial artery occlusion, primary percutaneous coronary intervention, distal radial access, conventional transradial access
- Medical subject headings
- ST Elevation Myocardial Infarction, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal radial accessProcedure or surgery
primary percutaneous coronary intervention via distal radial access
conventional transradial accessProcedure or surgery
primary percutaneous coronary intervention via conventional transradial access
| Study group | Role | What they receive |
|---|---|---|
| distal radial access | Experimental | Distal radial access for primary percutaneous coronary intervention in STEMI patients Receives: Procedure: distal radial access |
| conventional transradial access | Active comparator | conventional transradial access for primary percutaneous coronary intervention in STEMI patients Receives: Procedure: conventional transradial access |
What is being measured
The primary outcome is the main question the study is designed to answer.
radial artery occlusion
The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.
Measured: at 24 hours after procedure
Secondary outcomes (10)
the rate of successful puncture
Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery.
Measured: Immediately post-procedurally
puncture time
The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion.
Measured: Immediately post-procedurally
first medical contact to device (FMC2D) time
FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation.
Measured: Immediately post-procedurally
procedural time
Procedural time defined as the time interval between local anesthesia to sheath removal.
Measured: Immediately post-procedurally
hemostasis time
Hemostasis time was defined as the time between sheath removal to complete hemostasis.
Measured: at 24 hours after procedure
access-related complications
Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma.
Measured: at 24 hours after procedure
hand function
Hand function was evaluated by QuickDASH questionnaire.
Measured: 1 week after procedure
radial artery occlusion
The radial artery occlusion will be evaluated 1 month after procedure by ultrasound.
Measured: 30days after procedure
radial aretry injury
Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography.
Measured: Immediately post-procedurally
major adverse cardiovascular events(MACE)
MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding.
Measured: 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start5 Jan 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Segment Elevation Myocardial InfarctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, open-label, parallel randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Luhe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jincheng Guo, Study chair, Beijing Luhe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461781
- Sponsor's protocol ID
- Beijing LH
- Acronym
- RAPIDIII
- Status last verified
- Mar 2025
- First submitted
- 14 Jul 2022
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Z, Wang Y, Song J, Wang S, Wang Y, Wu Y, Wang H, Liu Z, Yan R, Zhai G, Guo J. Distal radial access to prevent radial artery occlusion for STEMI patients (RAPID III): a randomized controlled trial. BMC Med. 2025 Mar 24;23(1):173. doi: 10.1186/s12916-025-04005-1.
PubMed 40128873
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion
- ClinicalTrials.gov ID
- NCT05461781
- Acronym / sponsor ID
- RAPIDIII / Beijing LH
- Keywords
- radial artery occlusion, primary percutaneous coronary intervention, distal radial access, conventional transradial access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Beijing Luhe HospitalUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 18 Jul 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.
Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.
Detailed description
Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, open-label, parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| distal radial access | Experimental | Procedure: distal radial accessDistal radial access for primary percutaneous coronary intervention in STEMI patients |
| conventional transradial access | Active comparator | Procedure: conventional transradial accessconventional transradial access for primary percutaneous coronary intervention in STEMI patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- ST-segment elevation myocardial infarction for primary percuteous coronary intervention
- Palpable pulses on both access sites of the radial artery
- Informed consent
Key exclusion criteria (8 listed)
- Thrombolysis before primary percutaneous coronary intervention
- Previous CABG or radio-cephalic fistula using radial artery
- Cardiogenic shock
- Severe arrhythmias
- Severe liver and kidney dysfunction
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 radial accessprimary percutaneous coronary intervention via distal radial access | Procedure or surgery | distal radial access |
| conventional transradial accessprimary percutaneous coronary intervention via conventional transradial access | Procedure or surgery | conventional transradial access |
Primary outcome
radial artery occlusion
Time frame: at 24 hours after procedure
The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.
10 secondary outcomes
the rate of successful puncture
Time frame: Immediately post-procedurally
puncture time
Time frame: Immediately post-procedurally
first medical contact to device (FMC2D) time
Time frame: Immediately post-procedurally
procedural time
Time frame: Immediately post-procedurally
hemostasis time
Time frame: at 24 hours after procedure
access-related complications
Time frame: at 24 hours after procedure
hand function
Time frame: 1 week after procedure
radial artery occlusion
Time frame: 30days after procedure
radial aretry injury
Time frame: Immediately post-procedurally
major adverse cardiovascular events(MACE)
Time frame: 30 days after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 40128873Li Z, Wang Y, Song J, Wang S, Wang Y, Wu Y, Wang H, Liu Z, Yan R, Zhai G, Guo J. Distal radial access to prevent radial artery occlusion for STEMI patients (RAPID III): a randomized controlled trial. BMC Med. 2025 Mar 24;23(1):173. doi: 10.1186/s12916-025-04005-1.
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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.
Jincheng Guo study chair
Beijing Luhe Hospital
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 radial access and conventional transradial access in people with ST Segment Elevation Myocardial Infarction, run by Beijing Luhe 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 11 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radial artery occlusion (time frame: at 24 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461781, which also lists 1 linked publication.
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 11 Mar 2025.