Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Distal Transradial Access for Coronary Angiography and Percutaneous Coronary Intervention.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948165
Recruitment Status : Completed
First Posted : May 13, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Héctor Hugo Escutia Cuevas, CMN "20 de Noviembre"

Brief 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.

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).


Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Distal Transradial Access

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Distal Transradial Access for Coronary Angiography and Percutaneous Coronary Intervention: An Observational Study in a Latin-American Centre
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 30, 2018

Group/Cohort Intervention/treatment
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.
Procedure: Distal Transradial Access
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Unsuccessful distal radial artery procedure [ Time Frame: 24 hours ]
    Incidence of arterial crossover



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with radial artery pulse palpable in the radial fossa.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • radial access used within the previous 6 weeks
  • proximal radial artery occlusion
  • refusal of registration admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948165


Locations
Layout table for location information
Mexico
National Medical Centre "November 20"
Mexico City, Ciudad De México, Mexico, 03104
Sponsors and Collaborators
CMN "20 de Noviembre"
Investigators
Layout table for investigator information
Study Chair: Roberto Muratalla-Gonzalez, MD CMN "20 de Noviembre"
Layout table for additonal information
Responsible Party: Héctor Hugo Escutia Cuevas, Clinical Professor, CMN "20 de Noviembre"
ClinicalTrials.gov Identifier: NCT03948165    
Other Study ID Numbers: 34.2018
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Héctor Hugo Escutia Cuevas, CMN "20 de Noviembre":
dTRA
transradial access
distal
coronary
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases