Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)

Radial Artery Occlusion Clinical Trial

— DAPRAO  

Official title:

Distal Radial Artery Approach to Prevent Radial Artery Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238026
• Other study ID #: INCAR-DG-DI-386-2019
• Status: Completed
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2020
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Perceptible radial artery pulse

• Diagnostic or interventional procedure feasible to be performed with radial access.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Radial Artery Occlusion

Intervention

Procedure:
• Distal radial artery approach
Use of distal radial artery approach in coronary angiography and angioplasty

Locations

Country	Name	City	State
Mexico	National Institute of Cardiology	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.