Coronary Artery DiseaseNCT03948165
Distal Transradial Access for Coronary Angiography and Percutaneous Coronary Intervention.
An observational study of Coronary Artery Disease, run by CMN "20 de Noviembre" at 1 site in Mexico.
Trial summary
Introduction: The distal radial technique which consists of canalizing the radial artery through the anatomical snuffbox has recently emerged as an alternative arterial intervention for diagnostic and therapeutic coronary catheterization. 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 Transradial Access
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 30 Nov 2017to 30 Dec 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Patients with radial artery pulse palpable in the radial fossa.
Who may be able to join
- Above 18 years old
- Undergoing diagnostic and/or therapeutic coronary angiography
- With palpable pulse at the level of the radial fossa
- With a positive Allen test
- A positive Barbeau test, except type D.
Who cannot join
- Patients with type D Barbeau test
- cardiogenic shock within the previous 48 hours
- anticoagulation contraindication
- uncontrolled arterial hypertension
- peripheral arterial disease
- proximal radial artery diameter by duplex ultrasound <1.9 mm
Show all 9Show fewer
- radial access used within the previous 6 weeks
- proximal radial artery occlusion
- refusal of registration admission
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Medical Centre "November 20"
Mexico City, Mexico City, 03104
About this study
Official title: Distal Transradial Access for Coronary Angiography and Percutaneous Coronary Intervention: An Observational Study in a Latin-American Centre
Introduction: The distal radial technique which consists of canalizing the radial artery through the anatomical snuffbox has recently emerged as an alternative arterial intervention for diagnostic and therapeutic coronary catheterization.
Aims: To evaluate the feasibility and safety of the distal transradial approach (dTRA) as a default route for coronary angiography (CAG) and percutaneous coronary intervention (PCI).
Read the detailed description
Conventional transradial intervention is now considered the first intention technique for coronary access. The principal advantages are the increase in safety due to the reduction of major bleeding complications, as well as an increase in the patient's comfort due to the immediate post-procedure mobilization.
The safety of conventional transradial catheterization is determined mainly by the favorable anatomical relationship between the radial artery and the adjacent structures. No important vein or nerve is located near the artery, which minimizes the chances of damaging these structures. Due to the superficial trajectory of the radial artery, hemostasis can be easily performed with local compression. Traumatic or thrombotic arterial occlusion does not put the viability of the hand at risk while there is an adequate collateral blood flow from the ulnar artery, or from the interosseous artery.
Among the expected complications and limitations for future interventions is radial artery occlusion, which is estimated to occur in 1-10% of patients undergoing transradial intervention, and it has been considered the "Achilles heel" of transradial intervention for patients who eventually require new coronary interventions due to the complexity of their cardiac disease, because it originates in the sheath insertion site due to endothelial damage, blood flow cessation, and secondary thrombosis, and has an early occurrence after transradial catheterization. The radial artery occlusion is clinically silent due to the blood flow supply through the ulnar artery, which becomes a significant problem just at the time of the study execution, enhancing the interventionist cardiologist to perform a new vascular access.
The distal radial technique, which consists of canalizing the radial artery through the anatomical structure called the snuffbox (anatomical snuffbox, radial fossa, fovea radialis) on the dorsal aspect of the hand, has recently emerged as an alternative arterial intervention for diagnostic and therapeutic coronary catheterization, allowing the conservation of the radial artery for classical transradial intervention in patients who, according to the complexity of their heart disease, require new coronary interventions.
Another important characteristic of this technique is a proximal puncture of the short artery of the thumb and distally to the branch that irrigates the superficial palmar arch. This is because an occlusion at this site maintains anterograde flow towards the superficial palmar arch. This reduces the risk of formation of retrograde thrombus in the proximal radial artery located in the forearm, a frequent finding in patients who develop radial artery occlusion due to traumatic punctures or traumatic hemostasis at the traditional radial puncture site. Flow towards the thumb is maintained by way of the superficial palmar arch, preventing ischemia and disability of the hand.
This technique of distal transradial intervention has been performed in Mexico since 2017. The present research aims to describe the characteristics, complications, and benefits of this procedure carried out on a consecutive series of patients in a Latin-American centre.
- Conditions
- Coronary Artery Disease
- Being tested
- Distal Transradial Access
- Keywords
- dTRA, transradial access, distal, coronary
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Transradial AccessProcedure or surgery
The distal radial artery needs to be punctured with specialized equipment with a 20, 21 or 22-gauge puncture needle, using a transfixion or anterior wall technique. A 0.025 in, 46 cm guide was introduced in the system, followed by the introduction of the 5 Fr, 6 Fr, 7Fr hydrophilic arterial sheath or 5 Fr, 6 Fr or 7 Fr Glidesheath Slender introducer (TerumoIS, Tokyo, Japan), after a small incision in the skin.
| Study group | Role | What they receive |
|---|---|---|
| Distal Radial Approach | Distal transradial access will be performed on patients above 18 years of age, undergoing diagnostic and/or therapeutic coronary angiography, with palpable pulse at the level of the radial fossa, and these patients will be also subjected to the following tests: Allen maneuver and Barbeau maneuver; a positive Allen test was indication to perform the transradial access, while a type D Barbeau test will be a contraindication for it. Receives: Procedure: Distal Transradial Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications associated with the procedure
Complications associated with the procedure: haematoma, ecchymosis, bleeding, arterial dissection, thrombosis, radial artery occlusion.
Measured: 24 hours
Secondary outcomes (1)
Unsuccessful distal radial artery procedure
Incidence of arterial crossover
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start30 Nov 2017
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- CMN "20 de Noviembre"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Héctor Hugo Escutia Cuevas, CMN "20 de Noviembre"
- Investigators
- Roberto Muratalla-Gonzalez, MD, Study chair, CMN "20 de Noviembre"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948165
- Sponsor's protocol ID
- 34.2018
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Transradial Access for Coronary Angiography and Percutaneous Coronary Intervention: An Observational Study in a Latin-American Centre
- ClinicalTrials.gov ID
- NCT03948165
- Acronym / sponsor ID
- 34.2018
- Conditions
- Coronary Artery Disease
- Keywords
- dTRA, transradial access, distal, coronary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CMN "20 de Noviembre"University, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 13 May 2019 (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.
Introduction: The distal radial technique which consists of canalizing the radial artery through the anatomical snuffbox has recently emerged as an alternative arterial intervention for diagnostic and therapeutic coronary catheterization.
Aims: To evaluate the feasibility and safety of the distal transradial approach (dTRA) as a default route for coronary angiography (CAG) and percutaneous coronary intervention (PCI).
Detailed description
Conventional transradial intervention is now considered the first intention technique for coronary access. The principal advantages are the increase in safety due to the reduction of major bleeding complications, as well as an increase in the patient's comfort due to the immediate post-procedure mobilization.
The safety of conventional transradial catheterization is determined mainly by the favorable anatomical relationship between the radial artery and the adjacent structures. No important vein or nerve is located near the artery, which minimizes the chances of damaging these structures. Due to the superficial trajectory of the radial artery, hemostasis can be easily performed with local compression. Traumatic or thrombotic arterial occlusion does not put the viability of the hand at risk while there is an adequate collateral blood flow from the ulnar artery, or from the interosseous artery.
Among the expected complications and limitations for future interventions is radial artery occlusion, which is estimated to occur in 1-10% of patients undergoing transradial intervention, and it has been considered the "Achilles heel" of transradial intervention for patients who eventually require new coronary interventions due to the complexity of their cardiac disease, because it originates in the sheath insertion site due to endothelial damage, blood flow cessation, and secondary thrombosis, and has an early occurrence after transradial catheterization. The radial artery occlusion is clinically silent due to the blood flow supply through the ulnar artery, which becomes a significant problem just at the time of the study execution, enhancing the interventionist cardiologist to perform a new vascular access.
The distal radial technique, which consists of canalizing the radial artery through the anatomical structure called the snuffbox (anatomical snuffbox, radial fossa, fovea radialis) on the dorsal aspect of the hand, has recently emerged as an alternative arterial intervention for diagnostic and therapeutic coronary catheterization, allowing the conservation of the radial artery for classical transradial intervention in patients who, according to the complexity of their heart disease, require new coronary interventions.
Another important characteristic of this technique is a proximal puncture of the short artery of the thumb and distally to the branch that irrigates the superficial palmar arch. This is because an occlusion at this site maintains anterograde flow towards the superficial palmar arch. This reduces the risk of formation of retrograde thrombus in the proximal radial artery located in the forearm, a frequent finding in patients who develop radial artery occlusion due to traumatic punctures or traumatic hemostasis at the traditional radial puncture site. Flow towards the thumb is maintained by way of the superficial palmar arch, preventing ischemia and disability of the hand.
This technique of distal transradial intervention has been performed in Mexico since 2017. The present research aims to describe the characteristics, complications, and benefits of this procedure carried out on a consecutive series of patients in a Latin-American centre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal Radial Approach | – | Procedure: Distal Transradial AccessDistal transradial access will be performed on patients above 18 years of age, undergoing diagnostic and/or therapeutic coronary angiography, with palpable pulse at the level of the radial fossa, and these patients will be also subjected to the following tests: Allen maneuver and Barbeau maneuver; a positive Allen test was indication to perform the transradial access, while a type D Barbeau test will be a contraindication for it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with radial artery pulse palpable in the radial fossa.
Key inclusion criteria (5 listed)
- Above 18 years old
- Undergoing diagnostic and/or therapeutic coronary angiography
- With palpable pulse at the level of the radial fossa
- With a positive Allen test
- A positive Barbeau test, except type D.
Key exclusion criteria (9 listed)
- Patients with type D Barbeau test
- cardiogenic shock within the previous 48 hours
- anticoagulation contraindication
- uncontrolled arterial hypertension
- peripheral arterial disease
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 Transradial AccessThe distal radial artery needs to be punctured with specialized equipment with a 20, 21 or 22-gauge puncture needle, using a transfixion or anterior wall technique. A 0.025 in, 46 cm guide was introduced in the system, followed by the introduction of the 5 Fr, 6 Fr, 7Fr hydrophilic arterial sheath or 5 Fr, 6 Fr or 7 Fr Glidesheath Slender introducer (TerumoIS, Tokyo, Japan), after a small incision in the skin. | Procedure or surgery | Distal Radial Approach |
Primary outcome
Incidence of complications associated with the procedure
Time frame: 24 hours
Complications associated with the procedure: haematoma, ecchymosis, bleeding, arterial dissection, thrombosis, radial artery occlusion.
1 secondary outcome
Unsuccessful distal radial artery procedure
Time frame: 24 hours
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 14 May 2019.
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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.
Roberto Muratalla-Gonzalez, MD study chair
CMN "20 de Noviembre"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by CMN "20 de Noviembre" 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 5 inclusion and 9 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 14 May 2019. 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?
Incidence of complications associated with the procedure (time frame: 24 hours). 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 14 May 2019.