Coronary Artery DiseaseNCT05066074
Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique
A study testing Distal Radial Vascular Access in people with Coronary Artery Disease, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Distal Radial Vascular Access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- 16 Aug 2021to 1 Jun 2022
- 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
- Patients over 18 years
- Clinical indication for coronary angiography / angioplasty
- Palpable radial and distal radial pulse
- Previous clinical Barbeau test
- Radial and distal radial patency via vascular ultrasound
- 24-hour and 30-day follow-up feasibility
Who cannot join
- Previous vascular punctions in the studied anatomic site
- Artery introductor relationship
- Arteriovenous fistula
- Current treatment with oral anticoagulants
- Contraindication for Heparin
- Incomplete medical records
- Vascular access sheath - radial artery mismatch
- Distal radial or ulnar fracture history
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano del Seguro Social
Tijuana, Estado de Baja California, 22226
About this study
Official title: Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures
The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.
Read the detailed description
Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.
- Conditions
- Coronary Artery Disease
- Being tested
- Distal Radial Vascular Access
- Keywords
- radial artery, distal radial artery, vascular access, radial artery occlusion
- Medical subject headings
- Coronary Artery Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Radial Vascular AccessProcedure or surgery
Also called dTRA
Distal Radial Vascular Access
| Study group | Role | What they receive |
|---|---|---|
| Distal Radial Access | Experimental | Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization Receives: Procedure: Distal Radial Vascular Access |
| Proximal Radial Access | Active comparator | Proximal Radial Vascular Access prior to catheterization Receives: Procedure: Distal Radial Vascular Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Access Time
Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.
Measured: Seconds during the procedure
Secondary outcomes (2)
"Conventional" Radial Artery Occlusion
Radial Artery Occlusion using vascular ultrasound
Measured: In the first 24 hours, and follow up to 30 days
Distal Radial Artery Occlusion
Distal Radial Artery Occlusion using vascular ultrasound
Measured: In the first 24 hours, and follow up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start16 Aug 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Manuel Alonso Abril Lee, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066074
- Sponsor's protocol ID
- 17 C102 004 049
- Status last verified
- Nov 2021
- First submitted
- 14 Sep 2021
- Last updated
- 24 Nov 2021
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures
- ClinicalTrials.gov ID
- NCT05066074
- Acronym / sponsor ID
- 17 C102 004 049
- Conditions
- Coronary Artery Disease
- Keywords
- radial artery, distal radial artery, vascular access, radial artery occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 4 Oct 2021 (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 investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.
Detailed description
Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0
| Arm | Type | Receives |
|---|---|---|
| Distal Radial Access | Experimental | Procedure: Distal Radial Vascular AccessDistal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization |
| Proximal Radial Access | Active comparator | Procedure: Distal Radial Vascular AccessProximal Radial Vascular Access prior to catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years
- Clinical indication for coronary angiography / angioplasty
- Palpable radial and distal radial pulse
- Previous clinical Barbeau test
- Radial and distal radial patency via vascular ultrasound
Key exclusion criteria (8 listed)
- Previous vascular punctions in the studied anatomic site
- Artery introductor relationship
- Arteriovenous fistula
- Current treatment with oral anticoagulants
- Contraindication for Heparin
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 Vascular AccessAlso: dTRADistal Radial Vascular Access | Procedure or surgery | Distal Radial Access, Proximal Radial Access |
Primary outcome
Vascular Access Time
Time frame: Seconds during the procedure
Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.
2 secondary outcomes
"Conventional" Radial Artery Occlusion
Time frame: In the first 24 hours, and follow up to 30 days
Distal Radial Artery Occlusion
Time frame: In the first 24 hours, and follow up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- 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 Vascular Access in people with Coronary Artery Disease, run by Instituto Mexicano del Seguro Social 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 6 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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?
Results are not available in the source record.
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?
Vascular Access Time (time frame: Seconds during the procedure). 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 24 Nov 2021.