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

Primary Purpose

Radial Artery Occlusion

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Distal radial artery approach
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radial Artery Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • National Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distal radial artery approach

Proximal radial artery approach

Arm Description

Puncture in the snuff box area of the arm with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer.

Puncture in the ventral side of the arm (2 cm proximal to the styloid apophysis) with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2020
Last Updated
June 25, 2020
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
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1. Study Identification

Unique Protocol Identification Number
NCT04238026
Brief Title
Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)
Acronym
DAPRAO
Official Title
Distal Radial Artery Approach to Prevent Radial Artery Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Occlusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two randomized groups, one receiving traditional radial access and the other receiven distal radial access
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distal radial artery approach
Arm Type
Experimental
Arm Description
Puncture in the snuff box area of the arm with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer.
Arm Title
Proximal radial artery approach
Arm Type
Active Comparator
Arm Description
Puncture in the ventral side of the arm (2 cm proximal to the styloid apophysis) with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer.
Intervention Type
Procedure
Intervention Name(s)
Distal radial artery approach
Intervention Description
Use of distal radial artery approach in coronary angiography and angioplasty
Primary Outcome Measure Information:
Title
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.
Description
The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
National Institute of Cardiology
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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