Radial Artery OcclusionDAPRAONCT04238026
Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)
A study testing Distal radial artery approach in people with Radial Artery Occlusion, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
The main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion
- What is being tested?
- Distal radial artery approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteMexico
- Study dates
- 2 May 2019to 31 Mar 2020
- 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
- Perceptible radial artery pulse
- Diagnostic or interventional procedure feasible to be performed with radial access.
Who cannot join
- Myocardial infarction with ST segment elevation in time for primary angioplasty.
- Cardiogenic shock or hemodynamic instability.
- Clinical, plethysmography or ultrasound suggestive of occlusion of the radial artery
- Prior recent radial artery access (1 month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distal Radial Artery Approach to Prevent Radial Artery Occlusion
The main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Observational studies suggest that distal radial access could reduce RAO incidence.
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. The safety endpoint is the incidence of complications between these two methods.
- Conditions
- Radial Artery Occlusion
- Being tested
- Distal radial artery approach
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radial artery approachProcedure or surgery
Use of distal radial artery approach in coronary angiography and angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Distal radial artery approach | Experimental | Puncture in the snuff box area of the arm with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer. Receives: Procedure: Distal radial artery approach |
| Proximal radial artery approach | Active comparator | Puncture in the ventral side of the arm (2 cm proximal to the styloid apophysis) with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer. Receives: Procedure: Distal radial artery approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.
Measured: The RAO will be evaluated 24 hours after the procedure by ultrasound examination and was defined as the absence of both color pattern and pulsed wave registry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start2 May 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies 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
- Two randomized groups, one receiving traditional radial access and the other receiven distal radial access
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin Jimenez-Castellanos, Instituto Nacional de Cardiologia Ignacio Chavez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238026
- Sponsor's protocol ID
- INCAR-DG-DI-386-2019
- Acronym
- DAPRAO
- Status last verified
- Jun 2020
- First submitted
- 18 Jan 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radial Artery Approach to Prevent Radial Artery Occlusion
- ClinicalTrials.gov ID
- NCT04238026
- Acronym / sponsor ID
- DAPRAO / INCAR-DG-DI-386-2019
- Conditions
- Radial Artery Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Jan 2020 (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 main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Observational studies suggest that distal radial access could reduce RAO incidence.
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. The safety endpoint is the incidence of complications between these two methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two randomized groups, one receiving traditional radial access and the other receiven distal radial access
| Arm | Type | Receives |
|---|---|---|
| Distal radial artery approach | Experimental | Procedure: Distal radial artery approachPuncture in the snuff box area of the arm with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer. |
| Proximal radial artery approach | Active comparator | Procedure: Distal radial artery approachPuncture in the ventral side of the arm (2 cm proximal to the styloid apophysis) with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Perceptible radial artery pulse
- Diagnostic or interventional procedure feasible to be performed with radial access.
Key exclusion criteria (4 listed)
- Myocardial infarction with ST segment elevation in time for primary angioplasty.
- Cardiogenic shock or hemodynamic instability.
- Clinical, plethysmography or ultrasound suggestive of occlusion of the radial artery
- Prior recent radial artery access (1 month)
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 artery approachUse of distal radial artery approach in coronary angiography and angioplasty | Procedure or surgery | Distal radial artery approach, Proximal radial artery approach |
Primary outcome
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.
Time frame: The RAO will be evaluated 24 hours after the procedure by ultrasound examination and was defined as the absence of both color pattern and pulsed wave registry.
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.
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 29 Jun 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 artery approach in people with Radial Artery Occlusion, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 2 inclusion and 4 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 29 Jun 2020. 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 Mexico. 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?
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. (time frame: The RAO will be evaluated 24 hours after the procedure by ultrasound examination and was defined as the absence of both color pattern and pulsed wave registry.). 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 29 Jun 2020.