Distal Transradial Access for Coronary Angiography and Percutaneous Coronary Intervention.

NCT03948165 | Completed DMC

• 1 other identifier: 34.2018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

dTRA; transradial access; distal; coronary

Outcome Measures

Primary Outcomes (1)

• Incidence of complications associated with the procedure

  Complications associated with the procedure: haematoma, ecchymosis, bleeding, arterial dissection, thrombosis, radial artery occlusion.

  24 hours

Secondary Outcomes (1)

• Unsuccessful distal radial artery procedure

  24 hours

Study Arms (1)

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

Interventions

Distal Transradial Access PROCEDURE

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.

Distal Radial Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with radial artery pulse palpable in the radial fossa.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CMN "20 de Noviembre": lead

Study Sites (1)

National Medical Centre "November 20"

Mexico City, Mexico City, 03104, Mexico

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Roberto Muratalla-Gonzalez, MD

  CMN "20 de Noviembre"

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: November 30, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

ME (1)